U. S. Food and Drug Administration
U. S. Department of Agriculture
December 5, 1997
GUIDANCE ON GOOD AGRICULTURAL AND
MANUFACTURING PRACTICES FOR
FRUITS AND VEGETABLES
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PUBLIC HEARING
HELD ON FRIDAY, DECEMBER 5, 1997 AT
THE CLAYTON HUTCHESON AGRICULTURAL CENTER
559 NORTH MILITARY TRAIL
WEST PALM BEACH, FLORIDA
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PANEL MEMBERS:
Lynn Isaacs, Regional Public Affairs Specialist, FDA
Mike Chappell, Acting District Director, Fla. Dist., FDA
John Vanderveen, Ph.D., Acting Deputy Center Director,
CFSAN, FDA
Martha Roberts, Ph.D., Deputy Commissioner for Food and
Safety, Florida State Department of Agriculture and
Consumer Services
Clayton Hutcheson, Director, Palm Beach County
Cooperative Extension Service
Douglas L. Archer, Ph.D., Chair and Professor, Food
Science and Human Nutrition, University of Florida
Richard Barnes, Food Safety Initiative Staff, FDA
SPEAKERS: PAGE:
Mike Chappell 6
Dr. John Vanderveen 14
Dr. Martha Roberts 19
Clayton Hutcheson 28
Dr. Douglas Archer 29
Richard Barnes 37
Q & A Session 103
Dr. Ricardo Gomez 121
Dr. Stacey Zawel 136
Mike Stuart 138
Bobby McKown 149
Dr. Chip Hinton 158
Dr. Mohammed Ismail 169
Dan Riche 185
Wes Roan 195
Dr. Jean Malecki 203
Gary Smigle 216
Mary Dettmars 218
Al Yamada 224
Rebecca Schleifer 229
Stephen Paige 232
Dr. Stacey Zawel 238
Dr. Mohammed Ismail 240
Lauren Gould 241
- - -
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(The following Public Hearing commenced at
9:10 a.m.)
MS. ISAACS: Good morning. Thank you for
joining us this morning, and we also thank our
head table of participants for weathering the
weather yesterday and joining us.
You all should have a copy of the agenda in
your packets, the new and improved agenda as of
this morning, and I'm going to go through here
and briefly introduce our participants here.
Down at the far end is Dr. John Vanderveen.
John is the Acting Deputy Center Director with
FDA Center for Food Safety and Applied Nutrition.
Next to John is my boss, Mike Chappell, the
Acting District Director of the FDA Florida
District Office.
And next to Mike is Dr. Martha Roberts.
Martha is the Deputy Commissioner for Food Safety
with the Florida Department of Agriculture and
Consumer Services.
And then we have former FDA'er, Dr. Douglas
Archer, who is a Chair and Professor, Food Safety
with the University of Florida, Food Science and
Human Nutrition.
Did I get that sort of right, Dr. Archer?
4
DR. ARCHER: Certainly.
MS. ISAACS: All right. Just checking.
John, who was going to introduce Terry, but
I guess I'm introducing Terry. Terry Troxell.
What is your title, Terry, with CFSAN?
MR. TROXELL: Director of Programs and
Enforcement Policy Commission and of Dairy, Food
and Beverages.
MS. ISAACS: And one of the drafters of the
document.
Okay. And we have my other boss, Richard
Barnes, is the Director of FDA's Division of
Federal State Relations in Rockville, Maryland.
And we have Clayton Hutcheson. Clayton is
the Director of Palm Beach County Cooperative
Extension Service, whom I'm sure a lot of you
know, and we certainly appreciate his hospitality
today and he's going to be giving some welcoming
remarks.
Okay. Let's give a little background
information about this initiative. On
October 2nd of this year, President Clinton
announced a plan entitled Initiative to Ensure
the Safety of Imported and Domestic Fruits and
Vegetables.
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As part of this initiative, the President
directed the Secretary of Health and Human
Services, in conjunction with the Secretary of
Agriculture, and in close cooperation with the
agricultural community, to issue guidance on good
agricultural practices, affectionately referred
to as GAPS?
Do you call them GAPS, too?
MR. TROXELL: GAPS.
MS. ISAACS: GAPS. And good manufacturing
practices, GMPs for fruits and vegetables.
FDA and USDA have developed draft working
papers that addressed microbial food safety
hazards and good management practices associated
with water quality, sanitation, hygiene,
transportation, manure and municipal sludge
common to the growing and harvesting of most
fruits and vegetables that are sold to consumers
in an unprocessed or minimally processed form.
These preliminary drafts are intended to be
further developed and refined to assist growers
and handlers in examining their operations for
potential microbial hazards, and in identifying
management practice options that may be adopted
to minimize the risks of microbial contamination
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for fresh produce.
So the purpose of this meeting is to solicit
your input on this draft guide. This meeting is
part of a series of town hall meetings that are
being held across the country. A public meeting
was held in Washington, D. C. on November 17th
and approximately 150 people attended. Comments
from that public meeting are included in the
draft of the guide that will be presented today.
I believe there is going to be another
meeting Monday to address international concerns;
that's also in the Washington, D. C. area.
Grassroots town hall meetings have also been
held this week in Grand Rapids, Michigan on
Monday, they had about a hundred folks there, and
Geneva, New York on Wednesday attracted about 75
attendees.
So today we hope to get your comments, your
reactions to this draft guide and, later on, if
you get home and think of additional points, you
can go ahead and submit a written comment to the
FDA.
Your information packet includes an
announcement for this meeting, and that
announcement tells you where to send additional
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comments, and it's very important that you
include the docket number with that comment. So
we encourage you to do so after we go away today.
This meeting is being transcribed so that
the scientists preparing the guidance document
can carefully review your comments and make
revisions to the document as appropriate.
As far as housekeeping, some of you may have
found the rest rooms already right outside the
entrance. There will be coffee, we hope. It has
been ordered. There are several restaurants
close by, and Clayton has provided a map to the
ones closest to us. We really want to just break
for one hour for lunch and be back here to get
the input from you all.
We hope that you all picked up an
information packet about FDA and USDA at the
registration desk. And we intend that today's
meeting will be informal; you will have ample
opportunity for comment.
As you see from the agenda that we're
scheduled to adjourn at 4:00 o'clock, but I'm
sure if there's a lot of interest, that everybody
will stay till the last person is heard. Am I
right?
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Okay. In addition, if some of you don't
really want to make your comments orally, we have
a little written two-part form, comments,
questions, and Frank Goodwin has those available
for you; just fill it out and raise your hand and
Frank will collect it and we'll get it to the
right panelist up here and address your concern,
and I'll read your comment or question.
Okay? Are there any questions thus far?
All right. Well, let's start off with Mike
Chappell.
MR. CHAPPELL: Good morning.
I think if we're going to hear from these
people, we're going to have to have a little more
enthusiasm.
MS. ISAACS: Try it again.
MR. CHAPPELL: Good morning. A little
better. You might want to tone them down toward
the end of the day.
Well, I'm here on behalf of the Food and
Drug Administration to welcome you to this town
meeting, as well as representing John Turner, who
is the regional director for the Southeast Region
of the Food and Drug Administration.
I'd like to emphasize a few points, very few
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points about the President's Initiative and our
purpose here today. First of all, it is a
collaborative effort. It includes the United
States Department of Agriculture and state and
local Departments of Agriculture, and,
importantly, for today's meeting, it includes
you.
As Lynn mentioned, this is one of a series
of meetings -- I think this is the third of six,
I guess we held them last week, and there will be
some next week also -- throughout the country to
hear your concerns. The meeting that Lynn
mentioned on Monday in Washington, December the
8th, will deal with international concerns.
The use of the town meeting is -- or the
grassroots meeting is fairly new to FDA. We,
really, over the last few years as part of, I
guess, a re-invention of government, we began to
use these instruments more in getting people's
input earlier on in the process of developing
guidelines and regulations.
And it's certainly appropriate to do that,
because if you look at the history of this
country, that is a forum that has been used
throughout history to understand what the people
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really need, the people really want, and the
people's concerns.
So this is a forum; this is your forum, this
is your opportunity to speak with us, to share
with us your concerns and certainly understand
what we're going to be giving you today and
presenting to you. Certainly, we ask that you be
frank, you be open with us, and we'll certainly
do the same with you.
I think it's very appropriate that we're
having one of these meetings in the Southeast,
particularly here in Florida. The Southern
United States and Southeastern United States
produces a significant portion of the fresh
fruits and vegetables consumed in the United
States.
And it's also in this area where we have a
wide variety of representatives of the producers.
We have everything from the small family farm to
the major agribusinesses. And this is, again,
your opportunity to talk about these issues, to
understand these issues and let us know how you
feel about them.
I'd like to mention a little bit about -- I
mentioned the Southeast Region. The Southeast
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Region of the United States is composed of eight
states, the Commonwealth of Puerto Rico and the
U.S. Virgin Islands. There is a district --
district throughout the Southeast, they are
located in Atlanta, Orlando, San Juan, Nashville,
and New Orleans. There are about 500 of us. We
have two laboratories located, one in Atlanta and
one in San Juan. There's about 125 people
associated with those laboratories. The rest of
us in those district offices and the 28 other
support offices for those districts comprise the
500 people in the Southeast.
The laboratories analyze thousands of
products in the course of a year, generating
hundreds of different analyses to ensure that the
products that we regulate are safe, effective,
and wholesome.
The rest of us throughout the inter-lands
and in these other offices that I mentioned, are
basically the field investigational force; we do
the inspections, we conduct investigations in
support of the Food, Drug and Cosmetic Act and
other associated acts.
But FDA overall is involved in the
production, import, transport, storage, and
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monitoring of products that account for about
$750 billion a year in our economy. So we have a
major job and, of course, food safety is one of
FDA's major concerns.
It is our responsibility to make sure that
the food on American's tables is both safe and
wholesome. And part of that process is to try to
prevent problems before they occur. And as part
of that, one of the things we do is try to assess
risks associated with these products, and that is
one of the bases for our public health
commission.
Based on our public health responsibilities,
the President has charged FDA to take the lead in
developing a guidance document to assist farmers
in minimizing microbial hazards. I must
emphasize that we are developing guidance and not
regulations.
Those of us within FDA understand the
difference and we understand the possible
nuances. And I know for people who are not that
familiar with it, it may get muddled and one may
appear to be the other.
And I think as we go through the day -- and
I ask you to pay particular attention to this --
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we're going to talk about the differences between
guidance and regulations and how that really will
affect what this whole process is about.
The President's Initiative does not require
new regulations on microbial safety of foods.
You'll hear that repeatedly throughout the course
of the day and it's important for you to
understand that.
Richard Barnes, who is now part of the food
safety initiative -- I guess in his former life
he's a director of the Division of Federal State
Relations, and many of you may already know him,
but he'll talk a lot more about this -- the
regulation, per say, and the differences in the
guidance.
The task at hand is twofold for us: First,
we're going to review some of the major features
of President Clinton's initiative on fresh
produce, and Richard will give you some of the
background on that and the forces that led to it.
Secondly, and most importantly, we need to
have your input on the draft guidance on good
agricultural practices, which Lynn has already
referred to as GAPS.
The drafts in your information packet, it's
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fairly fresh, I think we got it just a few days
ago, and it represents our first stab at this.
It does represent input from the both the
sciences at USDA and FDA, and they represent only
preliminary thinking on our part.
Obviously, you have to have something to
start with, something to get the discussion
going, and that's what this is.
The produce subcommittee of the National
Advisory Committee on Microbial Criteria and
Foods, which is an advisory body to FDA, has
reviewed this draft, and it's my understanding
their comments have been incorporated.
So now it's your turn. We expect you to go
over this with us, give us your comments, ask
questions. It's really important that we
understand each other. If you don't understand
something we're saying, you need to be clear on
that. And, likewise, we need to be clear on your
thoughts and feelings.
All of these town hall meetings, all of
these grassroots meetings, the comments will be
carefully analyzed, they will be reviewed prior
to issuance of the final draft document, which
will be issued in the Federal Register early in
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1998.
Even after it's been issued, there will
certainly be a comment period, and you'll have
another opportunity to comment on that draft at
that point. It also will be -- it is now posted,
as I'm sure the -- when the final draft goes out,
will be posted on FDA's web site or Internet
site.
If you picked up one of these blue folders
outside, you already have the FDA Internet
address. It's on -- it's certainly on this
particular insert. If you haven't picked that
up, please do so. We've become so accustomed now
to using the Internet to provide information
that, in the field, this is the first place we go
to find out what's the most current thinking in
the various centers within FDA.
So I encourage you to use that to certainly
see what's happening, what's going on, not only
in this initiative, but in other areas of FDA.
Well, we got a little bit of a late start,
but I certainly want to make sure I don't step on
anybody's toes, talk about things that's going to
be addressed further, so I'm going to stop now.
But I do want to encourage you to be open,
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to be frank with us. We're here to listen, and
I'm sure that if -- there's going to be plenty of
time for questions and just so we can hear your
concerns and comments.
So with that, Lynn, I'll turn it back over
to you.
MS. ISAACS: Thank you, Mike. And the FDA
home page is www.fda.gov. And you will find a
wealth of information on it.
Okay. Dr. Vanderveen, you're next.
MR. VANDERVEEN: Thank you, Lynn.
I'm John Vanderveen, as Lynn has told you,
and I would like to extend my welcome to all the
welcomes that you'll get this morning on behalf
of the Center for Food Safety and Applied
Nutrition and all of our partners in this food
safety initiative.
And there are six partners; there's several
sections of USDA that are actively involved with
this. The Center for Disease Control, the
Environmental Protection Agency is playing a
significant role, and we are all very pleased
that you have taken the effort to come here
today. We recognize that you have busy
schedules, we recognize also that some of you
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have come long distances, and we're very pleased
that you're willing to make that effort.
I'd like to introduce one other person. I
think Camille Brewer is back there in the back of
the room. Camille is one of our compliance
officers, and she's been the project manager for
a number of these efforts, produce initiative
efforts, and she has been largely responsible for
organizing much of what you're going to see
today.
I would like to mention the fact right off
that we have the safest food supply in the world.
There is -- we continue to say that, we're very
proud of that. USDA regulating meat and poultry
and FDA regulating a good portion of the other
food supply. We are very, very pleased all the
time with the response that the farmers, the
processors, and retailers do in making our food
supply as safe as it is.
Nevertheless, there are problems from time
to time and we have to expect that, I guess, but
we always try to make things better.
As you heard, the President, two months ago,
initiated this produce initiative and we are very
anxious to fulfill the goals that he's outlined
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in this. But our main purpose is to gain from
you your advice, your counsel, your constructive
criticism and gain from the benefit of your
knowledge. I'm the first to admit that we can't
be in your shoes at all times and know all the
nuances that are important in trying to do what
we're trying to do in this area.
I want to acknowledge, also, that there has
been significant input to where we are at the
present time from the industry. The trade
associations, the educational arms of those trade
associations have played a significant role in
recent years in trying to guide us in what needs
to be done relative to such a guide as we're
trying to put forth today.
I've met with a number of trade associations
over the last two or three years; they have sent
me their materials and asked for my input to it,
and we're very pleased that they're working so
hard in this area, and we hope that this
relationship can continue in a very positive
manner.
There's more about this initiative on
produce that I want to emphasize and just take a
moment to do it. As you've already heard, this
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is a guidance document that we're trying to
prepare and we think it's very important for
various reasons.
It's about partnerships between government
agencies, farmers, transportation processors,
retailers, and even the consumer, and it's about
a new paradigm where the government will place
more emphasis on helping to prevent food safety
problems by establishing good agricultural
practices and good manufacturing practices and
less on traditional end item inspection and
testing.
We just don't have the resources; it's just
not a good way to operate, and as a consequence,
we want to enter into a much more -- we hope that
with Seafood HACCP you will see the results of
this partnership starting in January, and we will
soon have an in-juice HACCP proposal in the
Federal Register.
And we hope that you will understand that
this is a program where we're trying to work with
the industry and try to prevent problems and not
rely on the traditional compliance approach to
gaining food safety.
We want to establish also a dialogue, and we
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want you to be able to feel free to come in to
see us from time to time if you have problems.
We've always had our doors open to talk with
people and we want to emphasize that as well.
I think that there's one other aspect I
would like to talk about today, and that is the
fact that, in developing this guide, is for -- as
you'll hear today -- for our domestic industry,
but the guide is very important in dealing with
our trading partners as well.
As you know, there are various trade
agreements required, that we have standards that
are equal between those for domestic and those
for imports of all our products. And we must
start out by defining what our standards are, and
then only in that way can we say to foreign
governments, this is our standard and we expect
you to meet that standard.
So I emphasize that, although we're working
on a guide for domestic production of foods,
we're anxious to use that guide eventually as our
standard as what we expect from other imports to
this country.
In closing, I'd like to say just two things:
I appreciate very much Mr. Hutcheson's efforts to
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have us here in this very nice facility. I'm
with the 4-H -- I guess I was going to say
student -- but 4-H member for about 12 years 45
years ago, and I must say, things weren't quite
this good. We usually met in the middle of a
dairy farm barn floor or someplace like that, not
nearly as nice as this, and we certainly
appreciate your kind invitation here, and we hope
all of you will participate very fully today.
Thank you very much.
DR. ROBERTS: I bring you greetings from
State Government, Commissioner Bob Crawford,
Commissioner of Agriculture for the State of
Florida welcomes you, and we're delighted to be a
participant in this meeting and to gain
perspective from everyone involved.
We commend FDA and commend USDA for trying
to address this issue and for allowing
participation by state government, by industry,
by consumers, and all stakeholders.
Quite frankly, it's unbelievable that we
have a major political initiative that is very
scientific issue of food safety, and I think,
quite frankly, it puts us into a different arena
and casts some different perspectives that we're
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all having to deal with as we go forward on this
very major initiative.
So as state government, we're prepared to
work very closely with our federal partners, FDA
and USDA, to ensure that we have a very science-
based common sense guidance to the industry.
We're very pleased that FDA has been charged to
develop this in cooperation in partnership with
USDA and to set standards for imported and
domestic product.
Food safety is a major priority of the
Florida Department of Agriculture and Consumer
Services. It is the department's priority, it is
the public's priority, industry's priority,
universities and health professionals alike.
Within the department, we focus on the
potential microbial risk, attempting to prevent
it through good sanitation and hygiene and to
provide the safest food supply to our citizens in
our inspection and laboratory testing programs of
the State.
We're emphasizing examination for food-borne
pathogens, everything from Salmonella to E. coli
to Listeria, and would like analytical procedures
for other things, such as cyclospora that we have
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to deal with as food-borne risk in the State of
Florida.
The State of Florida is responsible for the
inspection and laboratory surveillance of over
28,000 retail food stores, warehouses, and
processing establishments in the State of
Florida. We have almost 300 individuals
associated with this program, and we're delighted
that one of these public meetings is held in the
State of Florida. We think it's a very
appropriate location.
For many years, this very county in which
we're seated was the fourth and fifth largest
agricultural county in the United States
producing over $1 billion in cash receipts in a
whole host of fruits and vegetables. But yet,
due to the impact of many government regulations,
state, federal, local, as well as increasing
competition from imports, within the last census,
we have seen this county dwindle from fourth or
fifth down to 11th.
We feel that this is an apt place to have
this hearing because of the diversities of
agriculture in this county. And it is also very
appropriate because this was one of the very
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first counties in the nation over three years ago
where we started experiencing so many cases of
food-borne illness from a unbefore recognized
parasite, cyclospora. I'm very glad that
Dr. Jean Malecki will be later talking a little
bit about that, as far as the numbers of cases
experienced here in this county from imported
strawberries.
And this county is also the site of some
very proactive citizen groups. We have some
senior citizen groups in the area that are
extremely active with the department, are trying
to do more in the whole area of helping the
department to enforce our country of origin
labeling laws so that the general public will
know the source of fruits and vegetables that
they are eating.
So we are a state in which we have a
tremendous partnership. Our philosophy in the
State of Florida has always been cooperative.
We've had innovative partnerships with federal
government, with state government, with local
government, with our industry groups, with
consumer groups, with our universities, and with
Extension Service, and we feel that that's the
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very best way to attack problems.
We're a state where every one of these
groups has, as their major focus, food safety
consumer issues and water and environment, and
they're all priorities for state government
federal consumer groups, industry and
universities alike.
So this partnership is excellent and we
focus on partnerships as the necessary step in
this guidance. But we'd also like to look at the
goal of health. And within my welcome, I'd like
to make a few comments relative to that, because
that is the ultimate goal of any GAPS or GMPs
relative to this industry, is to increase the
public health in this country.
And I am personally concerned that, as we
have any further drop in domestic production of
fruits and vegetables with any increased
importation from third world nations, that we
make certain that we apply the current
regulations on sanitation and production to the
importation from other nations.
It is very difficult for us to absorb
reports of all sewage and irrigation waters on
nations from which we're having product imported.
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If we reduce domestic production, have we
increased public health safety in this country,
and I do not think that we will have.
One of the major parts that we strongly
support in the document is the area concerning
water concerns and water impact on food safety.
We are a state that has very major complex
regulations involving water safety, water
quality, and the source of water.
Water in the State of Florida is regulated
very strictly by our five water management
districts as far as the Florida Department of
Environmental Protection. The actual water
allowed to be used by agriculture is given to
them on a water use permit that allocates to
agricultural uses specific quantities of water
annually and the specific source of that water.
So they could not, and it would be very difficult
to immediately change any source.
But the water use in agriculture is about
60 percent farm ground waters with about
80 percent of many of our industries already
having shifted to low volume drip irrigation.
Water we use is emphasized as a goal of the state
as far as use of reclaimed water, but edible
27
crops that will not be peeled, skinned, cooked,
or semi-processed before consumption are not
permitted to be using treated effluent.
We support any reasonable proposal that will
increase food safety in this nation. The number
of deaths and illnesses is unacceptable, but we
want to support something that will be based on
sound science, on advisory groups'
recommendations. We're very pleased that those
have been entered into the proposed draft.
We would hope that our federal counterparts
will support the additional research GAPS that
have been identified and that will base all these
good agricultural practice recommendations on
common sense and reality and risk to the public.
And we earnestly ask that what we have
currently in place as far as sanitary
requirements in the United States be initially
enforced on both domestic and imported product.
We need also to ensure that we're listening
to our voices, and that's why I want to commend
FDA and USDA for doing just that.
Today I'll be listening as a regulator.
I'll be listening with a regulator hat who's top
priority is food safety and who wants to ensure
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the highest degree of safety to the foods that
we're purchasing, the foods we're producing, the
foods we're consuming.
We've got about 14.7 million citizens in
this state and over 40 million annual visitors.
That's a lot of meals being served and it's a lot
of food safety requirements.
I'll be listening as a professional
microbiologist who's very concerned with the
threat of the condition of some of the imported
products that we're seeing from nations not
having adequate sanitation.
If I'm told not to eat salads or fruits and
vegetables in a nation I'm visiting, even in the
very best of restaurants, why would I want to buy
them and purchase them once they're imported into
the United States. That's a personal philosophy.
As a microbiologist, I also know that dirt
and fields are not sterile and they can't be. I
strongly support, though, the requirement that
you can't expose the food to untreated human or
animal waste.
I'm listening as a member of an agricultural
agency that knows the efforts of our agricultural
industry to try to address food safety concerns
29
and prevent contamination. And I'm also going to
be listening to you as a mother and a grandmother
because I want the safest and cheapest food
supply. I want it to continue; I want the older
and the younger members of my family not to be
submitted to any undue risk, but I also want them
to eat more fruits and vegetables because it's
the best way, and one that our National Academy
of Sciences has recognized as the best way to
prevent cancer and chronic human disease.
So I commend FDA for their activity and I
commend them on having the National Advisory
Committee on Microbiology for Criteria for Foods
to address this issue. We would ask you to
thoughtfully consider the committee's
recommendation and to pursue those with all care
and deliberation.
We want you to continue, as you're doing
here, to actively seek the input of all parties
and we're delighted at that. And we thank you
for letting the input of those who know how
fruits and vegetables are grown in real life to
provide information to you.
We want to all work together to seek the
highest level of safety for the U.S. food supply
30
and to aggressively apply current standards. We
want you to actively support country of origin
labeling, too, so that consumers can know where
the produce that they're eating has come from.
We look forward to hearing from the
industry, we look forward to continuing to work
with FDA because we're a state in which
partnerships are effective and we want to see the
President's Initiative soundly and reasonably
applied.
Thank you.
MR. HUTCHESON: I wanted to take just a
moment to welcome you on behalf of Dr. Chris
Waddill, dean and director of the Cooperative
Extension Service here in Florida, she couldn't
be here today. But the Extension Service here in
Florida has a commitment to carrying out the
educational role that has been given to us over
the years.
As I look at what's going on here today and
what may come out of it in the future, we have
dealt with and provided educational services for
training of pesticide applicators leading to
their certification when that came along, that's
happening, of course, throughout the United
31
States, and Extension Services came through on
that. The worker protection standards, when that
came along, the Extension Service geared up to
make sure that educational programs were there to
be delivered to the agricultural people.
So Dr. Waddill has renewed her commitment to
make sure that the Extension Service here in
Florida is able to deliver and to provide those
educational services that are going to make a
difference for the industry here in Florida.
Whatever comes out of this meeting today and
ultimately out of this process, the Extension
Service will probably be -- have a responsibility
for doing some part of the educational role that
will be certainly associated with this.
Since my role is to remain unbiased and not
make any inflammatory comments, I'm going to kind
of stop there and welcome you to the facility.
I might say, there are some members of the
press here today. We have some tables over along
the wall; if that's more convenient for you, feel
free to use those.
But, again, on behalf of Dr. Waddill and the
Extension Service here in Florida, welcome, and
we stand ready to support the industry and to
32
make life as easy as possible at the end of this
entire process.
Thank you.
DR. ARCHER: I'm Doug Archer. I'm from the
University of Florida which is the land grant
school here in the State. And I don't speak for
the University of Florida; if you know much about
academics, nobody can represent academics, they
all have their own opinions.
In any event, I'm allowed to make
inflammatory remarks, unlike Clayton, so I'll
make a couple.
We're here today to talk about this
document, this draft guide. And when I was with
FDA, the last ten years I was with the agency, I
spent in Washington, D.C., and there used to be a
rule of thumb in Washington that when you put
something out, it had to pass the hee-haw test,
and if you think about that, it becomes self-
explanatory.
And I have to admit, when I was reading
this, I did get a few hees and haws out of it. A
couple of them I'll just mention that I think the
agencies might want to reconsider are some
provisions such as covering reservoirs. I spent
33
$15,000 to cover my swimming pool and I still
have frogs, snakes and other things that crawl in
and out of it, so I don't think that's a
practical solution.
Another thing that I think they might want
to reconsider is the control of migratory birds.
I'm not aware that migratory birds have to land
in order to defecate and, frankly, I'd rather
have them on the ground where they probably
aren't going to saddle up to the green bean bush
to do their business, rather than indiscriminate
bombing overhead. So I don't think it's possible
to enforce no-fly zones over the entire southern
half of the State of Florida.
Now that might sound funny, but I don't
think it's funny for a variety of reasons. I
don't think it's funny if, in any way, these
efforts, through publicity or whatever, decrease
the consumption of fresh fruits and vegetables
from whatever source.
Remember -- and Dr. Roberts brought it up,
but it's very important that we keep in mind --
the consumption of fresh fruits and vegetables is
the single most important preventive public
health measure in the United States. It saves
34
more lives than food-borne disease takes ten
times over each year. And that is a fact, it's a
medically proven fact; it's not speculation.
Now, why is this effort happening at all?
Well, I think Dr. Roberts also alluded to that.
There is a good dollop of politics involved as
well as some reality. There have been some
outbreaks associated with fresh fruits and
vegetables.
But where I take exception with some of the
information in the guide are the examples that
have been chosen. I mean, there are some real
outbreaks that can be cited. But why confuse
processed foods with fresh produce? Why bring up
frozen coconut milk? I'm not aware that that's
fresh produce. Why give false examples of
outbreaks?
And I just pulled one because it happened
here in Florida, and it's in the guidance
document and it cites the outbreak in 1995
involving fresh-squeezed orange juice at a theme
park here in Florida. And the add-on to that is
that, although the cause of the contamination was
not identified, at least one of the groups
supplying oranges to the implicated processor
35
irrigated with surface water that may have been
contaminated.
Well, if that's not speculation on
speculation, I don't know what is. Because the
cause of that outbreak, I think, was pretty well
established, and it had nothing to do with
irrigation water. So why have things like this
in a document that's going to have any credence
on the outside.
I think what you'll hear today from a lot of
people is, this thing is going too fast. Now,
there's a reason for that. FDA is in the
executive branch of government, and the Chief
Executive of the United States told him to do it
in 90 days. And when he speaks, you do it in 9O
days.
I did the same thing, I had to do the same
thing when I was there. I never have experienced
anything quite like this in the 20 years I was
with the agency, but nevertheless, that's why
it's on a fast track.
I wish the process would slow down and I
wish that more time and more care could be given
to putting things down on paper; because once
they're down on paper, sometimes they're very
36
hard to erase.
Well, I've said some negative things, but
what are the positives? I think there are some
good things here and good things that need to be
considered. I think anything that decreases
illness in the United States is a positive thing,
and if this effort can do that, more power to it;
let's get down to work and find the things that
will have the most bang for the buck and do those
things.
But where should the effort be? I mean,
there's a lot in here on all kinds of things in
the growing field, and is that really where we
ought to be focusing our efforts. And I say no.
At least in my opinion, no.
What I don't see in here -- I see some
illusions to it coming in the future, but I
really believe that the biggest bang for the buck
would be anything that could empower the consumer
and the end product user of fresh produce.
Educate them, give them the knowledge they need
to treat the food safely, not to contaminate the
food and subsequently cause people to become ill,
which many of these outbreaks have really
involved, taking Neem juice, putting it on
37
lettuce, feeding it to people and wondering why
they become ill.
I think the other big bang for the buck
would be for the agencies that regulate either
disinfecting compounds or sanitizing compounds to
be able to put those, and assure producers that
those compounds could be put on a fast-track for
approval. Without that, we have chlorine and we
have precious little else that's been really
approved and blessed by the federal government in
the way of food additives.
I think those are two things that the
agencies could do and where they could devote a
lot of these resources to really, really make an
impact.
Thank you.
MS. ISAACS: Thank you, Dr. Archer.
And we do do a lot in the area of consumer
education already. We have a network of consumer
affairs officers, now called public affair
specialists, about 40 of us total nationwide, and
we do work very closely with Extension.
In fact, one of the programs that the
Florida District office started with Brevard
County Extension Service several years ago was
38
recently recognized with -- they received the
Vice President Gore's Hammer Award for Excellence
in Consumer Education. So I just had to add
that.
Our main focus this year is food safety for
seniors and it's an elder education project, and
most of the volunteers involved with this are
family community educators affiliated with
Extension. And this particular program has also
been extended to several other counties in
Florida. And in your package, you will also see
a variety of some FDA consumer education
materials.
Okay. Are there any questions at this
point?
You can see how we're going to proceed;
Mr. Barnes is going to present an overview of the
President's Initiative and get into the GAPS,
take a short break, hopefully, the coffee will
have arrived, and then he will continue with his
preview and any questions that you have that need
to be clarified, break for lunch, a short
presentation by USDA, additional questions, and
open it up to industry group presentations, a
number of which have been -- to start us off,
39
have been arranged by United Fruit & Vegetable
Association, Stacey Zawel.
Did I get that right, Stacey?
DR. ZAWEL: Pretty good, yeah.
MS. ISAACS: Okay. We thank you all for
your participation.
Then we will open it up to comments from any
other stakeholders.
Now, we have seven folks lined up from the
Fruit & Vegetable Association members who are
going to kick off the industry presentations.
And anyone else who knows now that they're going
to want to comment, can sign up over there at the
desk. We have an industry sign-up sheet, and
also all stakeholders' sign-up sheet just so that
we'll flow a little quicker.
Okay? Any questions? Stacey?
DR. ZAWEL: Should I go to the mike?
MS. ISAACS: Whatever.
DR. ZAWEL: Martha, I had a question. Stacey
Zawel with United Fresh Fruit & Vegetable
Association.
Martha, you had stated in your introduction
something about imported strawberry outbreak.
DR. ROBERTS: I meant imported raspberry
40
outbreak.
DR. ZAWEL: Okay. Thank you. I just wanted
to clarify.
MS. ISAACS: Okay. Anybody else?
DR. ROBERTS: Thank you for the correction.
MS. ISAACS: Okay. Mr. Barnes? Come on
down.
MR. BARNES: Good morning. My name, again,
is Richard Barnes, and I am one of the team
leaders for the Food Safety Initiative Team
working at FDA.
I've been with FDA a couple of years as the
Director of Federal State Relations. I came to
FDA from the State of Oklahoma, where I was
Director of Consumer Protection before going up
and deciding to work with the Food and Drug
Administration.
A couple things I'd like before I get into
the presentation to talk about how we got to this
point, the President's Initiative, and then
actually talk about the good agricultural
practices.
First of all, several people have said, you
know, this is a -- why pick on the fruits and
vegetables. And we really are not. This is part
41
of a total initiative, and I don't know if you've
seen this report to the President May of 1997.
Food safety from Farm to Table, a National Food
Safety Initiative.
And I'm involved, complete with all of the
food safety initiative involving all of this, as
well as the produce and import food safety
initiative part that is leading to the guide to
minimize microbial problems, hazards in fruits
and vegetables.
The process, the President's entire program
is exactly that; it's from farm to table. It
takes the whole system and puts it together into
a package. And so it talks about what -- this
part of it that we're talking about this morning
and what happens on the farm and the producers,
packers and so on that lead up to the retail
distribution chain, through the retail chain, and
all the way to the consumers.
Several weeks ago, the secretaries of USDA
and Health and Human Services announced the
campaign called Fight BAC, B-A-C, which is a
consumer campaign with four things they're
concerned about in educating the consumer on
handling foods.
42
The 1997 FDA Food Code has been produced and
is out for distribution, and part of the food
safety initiatives is to encourage jurisdictions,
agencies to adopt the Food Code, which contains
the best science available for the retail
industry. Upgrading and looking at more good
manufacturing practices; the use of HACCP, Hazard
Analysis and Critical Control Points throughout
the processing and manufacturing industry for
food products, and also in now looking at retail,
and where that fits and how that all goes
together.
So this Food Safety Initiative is a
composite of everything from farm to table. It
puts us all together, all of us, as food safety
people protecting each other to ensure the safety
of our food supply throughout the entire thing.
So that's one part that I want to bring up.
Secondly, I'm going to walk over here and
turn the overhead on, and I'll keep trying to
talk, hopefully, you can hear me, the group isn't
real large, so that you can hear me.
People have asked about the schedule. This
is the tentative schedule that, as Dr. Archer
said, we are held to by the President of the
43
United States in trying to meet the guides that
he wants for the Food Safety Initiative and the
Produce Food Safety Initiative.
In November, on the 12th or 17th, there was
a public meeting that was held in Washington, it
was also held with the Produce Subcommittee of
the National Advisory Committee for the
Microbiological Criteria for Foods. I have to
stop and think when I say that.
As a result of that, the working draft of
the guide was produced and put out, which all of
you have. And I would like to ask you, how many
of you have seen a copy of the guide prior to
today? How many of you have had a chance to
really look at it? Okay. Good.
In my presentation a little bit later -- I'm
not going to go through word for word of the
guide -- we want you to be able to take time to
look at it; those of you who haven't had a
chance, those of you who have to digest it, to
look at it, and to provide comments not only here
at the meeting, but also the written comments
that you're able to do through the end of
December. In January, we're going to compile and
evaluate all of these things that are being done.
44
Again, as we told you this morning or at the
beginning, there's a transcript being provided.
Those transcripts are going to be gone through by
the scientists at the agency. We're also looking
at bringing in our other people to assist us
during this entire process of the whole food
safety initiative; state people, industry people
that are going to assist in this whole process.
Then, from that, we're going to publish a
notice in the Federal Register sometime in March,
where there will be another comment period. At
the end of the comment period, there may be
another meeting, depending on what's necessary,
what comes out of all the comments. And then,
sometime in July or later, the availability of
the final guide will be produced.
Now, is this hard and fast, somebody said.
And as of yesterday, my meeting very early
yesterday morning, no, it is not. We are held to
what the President tells us, but some of it may
be shifted back a little bit, and that is based
on the comments that we're getting from people
from the first two grassroots meetings. So some
of this time line may be moved back somewhat as
we go through the process.
45
Okay. Any questions on that I'll take?
That's just a very brief overview of the
schedule.
Now I'm going to have to turn -- we're going
to use some slides, so I'll turn the lights down
a little bit when I get ready to do that, and if
I don't get lost in my notes, we'll be all set in
being able to read my notes from up here.
We encourage you to ask questions. One of
the reasons I came to the Food and Drug
Administration -- Dr. Vanderveen talked about the
change in paradigms -- and one of the reasons
that I applied and was very excited about going
to work for Food and Drug was the fact that I was
going to be a part of the change of the paradigms
at the agency.
I'm here and I like to be here and I'm glad
to present here because it involves my view and
my change of paradigm, my guess for this, and
that is that it involves everybody. It involves
the state, it involves the growers, it involves
the producers, it involves the consumers to have
input into things, which is a change from the way
things have been done in the past.
And so that's why I'm part of the team, is
46
to encourage and to make sure that I remind
everybody during the whole process that we want
the input from as many people as possible to make
sure that this is a consensus document; that this
guidance -- and I'm going to stress that word
over and over again -- that this guidance has the
input of everybody who wants to have something to
say into it before it's finalized.
Okay. If you could turn the slide projector
on for me please, Camille? See how we have to
adjust the lights.
Can you see that? Good.
Initiative to ensure the safety of imported
and domestic fruits and vegetables. In October
of 1997, the President announced a directive to
improve the safety of fruits and vegetables for
both domestic and those imported from foreign
countries. In his message, he wanted to develop
guidance to the industry that would not have the
force of regulation, that would not be a
regulation, but would provide guidance to the
industry, taking the input of everybody who was
interested to help improve the safety of fresh
fruits and vegetables to minimize the risk from
unsafe produce.
47
Again, several people already have talked
about the outbreaks that have occurred over the
past years, and there have been several of those
that have occurred from both domestic and from
imported produce, but the goal is that we want to
have the safest produce available to our
consumers.
And we do have that, and the President said
so in his message, that we do have a very safe
produce supply, but that we wanted to increase
it. And we want to increase it because both he,
the National Cancer Institute, the Food and Drug
Administration, the USDA, all support the idea
that more fruits and vegetables, fresh fruits and
vegetables are important to the health of our
nation and our citizens and our consumers.
We all know that the idea of having fresh
fruits and vegetables in our diet is important to
our national health and that we want to keep it
that way, we want to keep it safe and we want to
make it safer as we go through this entire
process of the farm to table food safety
initiative, improving the safety of foods all the
way along the line.
The elements of the initiative include a
48
legislative element, that one's already been
done. On November 23rd, a bill was introduced
into Congress to give the Food and Drug
Administration the authority to work on imported
foods very similar to what USDA, FSIS has for
meat and poultry products. It would allow us
to -- and I have some of the dates -- it was
supported by -- introduced in the House of
Representatives on November 13th, it's HR-3052,
it's called The Safety of Imported Food Act of
1997.
And essentially what it says is it changes
21-CFR, or the -- I'm sorry, not 21-CFR, but the
Food, Drug and Cosmetic Act, to add some language
that would allow the Food and Drug Administration
to look at foods that come into the country based
upon -- and I'll say that have not been imported
in the United States, that have not been
prepared, packed, and held under a system of
conditions or subject to measures that meet the
requirement of the Act, or otherwise achieve a
level of protection required as determined by the
secretary.
Well, there are several steps that the
agency must go through before that's done, and
49
there are several things that are different from
what the USDA has. There would be no
pre-approval, for example, what FSIS has is going
into foreign meat plants. We have to show as an
agency how we would enforce such a rule, how we
would implement it. We'd have to show that no
one would be denied entries of products into the
country or that there would be licensing or pre-
approval, for example, like low-acid canned
foods. So all of that has to take place as a
result of this legislative proposal before any of
it happens.
The administration portion of it is the
guidance to industry, which we're going to talk
about shortly, the good agricultural practices,
and eventually good manufacturing practices, as
well, to deal with that segment of the industry
from the farm up through other places where it is
controlled already under the CFRs.
And I hope that all of you understand when I
say CFRs, what I'm referring to it's the Code of
federal regulations; it's the documents that
guide the Federal Agencies and have the rules and
regulations written into them. 21 Series is the
Food and Drug Administration, for example, the 40
50
series is the Environmental Protection Agency,
and so on.
You're going to hear me talk a lot this
morning about good manufacturing practices that
are already in place for producers and
manufacturers. The good manufacturing practice
is Section 110 of the 21 CFR series.
And then there's also a budget request, and
that would be for '99, for FY99. There is no
money budgeted for this initiative in FY98. So
some of the things that would be done under it in
both domestically and imported for it would be in
FY99.
And the biggest requirement why we're here
today is that we had a requirement to report to
the President within 90 days of the October thing
on where we were and how we were going, how this
process was coming together, how the project was
working, good agricultural practices, good
manufacturing practices, what the schedule would
be for all of those things to get it done.
And as Dr. Archer said, the man that we work
for made the request that we do that in 90 days,
and we're trying to adhere to it as much as we
can.
51
Under the administrative section, the FDA,
in conglomeration with the USDA, is to issue,
within one year, the guidance for good
agricultural practices and guidance for good
manufacturing practices.
As a part of that, beside those guidance
documents, also, then, we're going to work
together to coordinate assistance and educational
activities to both domestic and the foreign
industry, the farming and producing industries,
and both of them will be done as a part of that.
Already, there has been cooperation between --
Cooperative Extension Service talks about doing
some of this, as well as hooking on to what's
being done, as I talked about earlier, on the
other Food Safety Initiative as well.
There it is again; guidance, not regulation.
Several people -- and we have said that you're
going to hear that too much, and perhaps I need
to just reinforce it again. That is the goal of
this document. We want it to be a guidance
document, an assessment, a self-assessment, to
use another word, for the growing community to
look at their practices, to help improve their
practices, to help increase the food safety or
52
the safety of food, fruits, and vegetables in the
in the food safety chain.
It's to help the farms, the growers, and the
producers identify the appropriate practices
where you can minimize microbial hazards. And
the cartoon underneath that is Fight BAC; that's
the one I talked about that's being geared
towards consumers in the country. There was a --
the secretary's released last month, you're going
to see more of him in many things.
And there's four areas, again, in that to go
along like the four areas of the good
agricultural practices; clean hands, avoid cross-
contamination, proper temperatures, and cooking.
Good Agricultural Practices, the Guide to
Minimizing Microbial Food Safety Risks for Fruits
and Vegetables is the document that we're going
to look at a little bit later. That's what they
want -- or the President wanted us to produce, to
do. It is a broad scope document. It is going
to be very broad.
Many of the things you've already heard this
morning, Dr. Roberts talking about the water in
Florida, for example, there will be sections of
the guidance document that are not going to
53
apply.
In other discussions we've had, for example,
the amount of manure that's used in vegetables
and fruit production in the State of Florida, for
example, is very minimal, except for chicken
litter, perhaps, in some areas. So it's going to
be different areas of the country that are going
to have different parts of that document be
important to them, depending upon local laws and
regulations, depending upon current practices.
And that's why we're here. Again, we're
here to let you tell us what things will work for
you, what won't, and if things are left out of
the document that we have not considered, that
those things get -- become a part of it as well.
We've already talked about the public
meeting that happened in November and these
meetings. The international meeting will occur
next Monday in Washington, D. C., and there also
is a second explanation of the good agricultural
practices meeting that's going to occur, I
believe, in Miami sometime next week.
Now this -- I left this slide in because it
was used at the other grassroots meetings.
However, I can tell you that the specific GAPS,
54
good agricultural practices, good manufacturing
practices for four fruits and vegetables is being
reconsidered. And as a result of the comments of
the grassroots meeting, although we never had any
criteria had been decided of what would be used
for these fresh fruits or vegetables, none had
been selected; it was intended that it will all
come through a public notice, a Federal Register
notice and public meetings.
At this point in time, as a result of the
first two grassroots meetings and input from the
industry, this is being reconsidered on whether
or not there will be some specific -- this year
or anytime in the near future -- whether there
will be specific good agricultural practices or
good manufacturing practices for four fresh
fruits and vegetables during FY98.
So I've left this slide up because it was
part of the other grassroots meetings, but also
tell that you this whole process for the specific
GAPS and GMPs is being reconsidered.
Outreach and educational activities are a
big part of this process. Assistance to the U.S.
farmer by the FDA and USDA on implementing the
good agricultural practices, the new FDA
55
Extension Service, educational programs,
assistance with people that you are used to
working with and being part of your farming
community to assist you in doing an assessment of
your growing practices.
There's also going to be, in FY98, technical
assistance to foreign countries. To initiate the
development of training modules and to coordinate
the development of non-FDA training network,
which might involve industry groups, which might
involve associations, which might involve private
entities, to provide technical assistance to
foreign countries using the same document to help
them to be sure that their -- the level of safety
of their produce is the same as ours.
That's a very quick overview of how we got
to here, of how the President put forth this
portion of the Food Safety Initiative.
Are there any questions I can answer about
this part of it anyway? Anything I've left out?
Yes?
MR. BROWL: Which of the four fruit and
vegetables --
MR. BARNES: Could you go to the microphone,
please? And also, state your name for us.
56
MR. BROWL: My name is Joseph Browl
(phonetic) I'm executive vice president of the
Florida Gift Fruit Shipper's Association.
Which of the four fruit or vegetable groups
you have considered or are still considering,
GAPS and GMPs in 1998?
MR. BARNES: None have been considered that
I'm aware of. The original proposal was that
there would be eight sometime selected, that
there would be specific good agricultural
practices or good manufacturing practices
selected for. None have been selected or even
looked at.
What was proposed was that through the
industry, through other means, eventually some
would be looked at. But as I said, that are now
being reconsidered and there are no -- at this
point in time anyway, there's a possibility that
that will not be done in the near future.
But that will happen with consultation with
everybody. Again, this is an open process.
Yes? Please go to the microphone, state
your name, please? I'm sorry, there's somebody
in the back, Stacey.
MR. ROBBINS: John Robbins, consulting
57
engineer in food sciences.
Is that a function of the criteria that's
involved, or is that a function of public comment
that there's nothing been added to that list?
MR. BARNES: The criteria were never
developed. There was never a criteria that we
had developed to that point in time.
What we had announced was that we would look
at some specific good agricultural practices for
some specific commodities. The criteria were
never developed to that point in time.
But as a result of the comments from the
first two grassroots meetings and from the
industry as a result of some other presentations,
that is being reconsidered on whether or not
there will be specific GAPS or GMPs for products.
MR. ROBBINS: Thank you.
MR. BARNES: Stacey?
DR. ZAWEL: Stacey Zawel with United Fresh
Fruit & Vegetable Association.
Richard, I missed something that you said
and wanted to get clarification on a Miami
meeting? What is that and what's it about?
MR. BARNES: Camille, help.
John, do you have that?
58
MR. VANDERVEEN: There will be -- I believe
there was another Miami meeting planned under a
different auspices and we are going to make a
presentation there.
I believe our director of the constituent
services is going to make that presentation.
There are a group of people from various
countries coming to be at that meeting anyway,
and it was an opportunity to inform them about
our program and our -- and our legislative
initiative, and that's an opportunity.
Do you have anything more to say on that,
Terry?
MR. BARNES: The meeting and, again, to
follow what John said, is a presentation; it's
not a grassroots meetings. It's a presentation.
MR. VANDERVEEN: That's right. It's just a
presentation.
MR. BARNES: Right. I'm sorry if I left you
with the impression that it's a grassroots
meeting. It is not.
MS. BREWER: It's a committee of Latin
American Action --
MR. BARNES: That's right. Latin American
Action Council.
59
MR. VANDERVEEN: This meeting was planned a
long time ago. It was put together by the
Foreign Aid Service. We were invited to
participate. It was designed to help with
providing information to countries about our
requirements in meeting the regulations that we
have for foods being sold in this country.
There were some other meetings planned in
other countries. I believe they're still going
to occur. The original focus had more to do with
pesticides and things of that sort.
MR. BARNES: Yes, ma'am?
DR. MALECKI: Hi, my name is Dr. Jean
Malecki, I'm a health officer here in Palm Beach
County.
And my question has to do with the document
itself, and I understand that it's one deeply
routed in values.
My concern, and probably this will be
discussed later -- if it wasn't going to be, I
hope it will be -- with all the guidance and
technical assistance that can be provided, my
concern is more of importation, what happens from
a regulatory standpoint if there is still
evidence of contamination?
60
MR. BARNES: Terry?
MR. TROXELL: Your question is, if we find
contamination on a product that's offered for
entry?
DR. MALECKI: If we still have continuing
human illness related --
MR. TROXELL: We would be able to take
action against those products under the Food,
Drug and Cosmetic Act.
DR. MALECKI: Well, in the past, we have
not. So I was wondering if there's going to be a
dialogue in the future in terms of relationships
contractually and so forth.
Right now, it's obvious to me that it's been
a consumer choice more than anything else. And,
again, my concern is, is that if we provide all
this guidance and technical assistance, again, my
concern is importation; what does ultimately
occur from epidemiological evidence, from public
health relationships with the folks as FDA would
have a health commission to either embargo or
stop sale.
MR. TROXELL: At this point, we would need,
under the FD&C Act, to make the link of a
poisonous or deleterious substance such as a
61
microbiological problem in the product, or that
the products were produced under unsanitary
conditions to prevent their importation.
DR. MALECKI: Thank you.
MR. BARNES: At one of the other grassroots
meetings -- and to show you that things are being
done all over the country and many of them have
been looked at in the process -- there is one
that -- one of the Cooperative Extension Services
had a brochure, Prevention of Food-Borne Illness
Begins on the Farm. And Dr. Archer, wherever you
went to -- one of the things -- I like words
anyway, and one of the first sections in here is
clean soil.
Any other questions on the first part of
this? We are waiting for coffee to be set up.
Would you like to take a short break now,
even though the coffee isn't ready, or would you
like me to go on and we'll take a break when that
gets done? We'll be flexible.
Go on? All right. We'll do that.
MS. ISAACS: Hold on, Richard.
MR. BARNES: We'll go about, maybe 15
minutes, 20 minutes?
MS. ISAACS: Okay. If you come back 15
62
minutes --
MR. BARNES: No, I thought they said go on.
MS. ISAACS: Oh, okay. All right.
MR. BARNES: So about 15 or 20 minutes and
then we'll take a break.
MS. ISAACS: Never mind.
MR. BARNES: Again, the scientists who work
on this document are in the room. When you ask
questions, if you ask me, for example, the time
and temperature requirements for composting
untreated manure in a 30 degrees centigrade
environment that's very damp, you'll see this
glazed look come across my face, and I'll start
pointing to someone.
And, also, I'm not going to go into
specifics of this whole document. We want you to
take some time to look at it, to develop opinions
on what it is. I'm going to highlight only
during this presentation what is in the guide to
minimize microbial food safety hazards for fresh
fruits and vegetables.
And so I'm going to talk about the document
in general. At the end, we'll do a short
question and answer period, then we will either
go to lunch, depending upon how we do on time.
63
Probably we'll go to lunch a little bit early and
then come back and then do the other
presentations.
The reason for the document in the beginning
of it talks about the reasons for this guide; the
recent outbreaks have raised concerns about the
safety of foods, including fresh fruits and
vegetables that are not processed to eliminate
pathogens.
And that's part of the problem. The problem
is that we do not have a way to eliminate
pathogens from some fresh fruits and vegetables.
You know the names of the microorganisms,
cyclospora, E. coli 0157:H7, Salmonella,
cryptosporidium. There are many organisms that
have been involved in outbreaks in recent years
involving fresh fruits and vegetables that are
difficult to remove. I mean, we don't have fried
lettuce sandwiches; we don't cook lettuce to 155
degrees for 15 seconds like we do a hamburger.
And so we have to be involved in the entire
process from farm to table in ensuring that we do
not -- we reduce or eliminate pathogens wherever
possible in that process.
They're not subject to many of the steps
64
that normally occur in food processing that would
eliminate or reduce microbial load that most
processed foods receive, or they aren't cooked.
Therefore, we have to find other ways to reduce
the microbial contamination, especially for raw
produce products.
And, again, at the same time, we have to do
that and what we're telling people eat more of
them; it's important to your health.
Potential vehicles for pathogenic
contamination, and which this document is divided
in, are into four areas; water, manure/municipal
sewage slush, water field facility sanitation
hygiene, and under transportation there is one
other area which is called the trace-back; where
we're now calling it positive lot identification
instead of trace- backs.
Again, as you've heard everybody say, it is
intended as guidance only; it's intended as
self-assessment. It's not a check list; it will
not contain everything that you need to know. We
will not have every bit of information that's
there. But it's to get you to think, to look at,
and evaluate your growing practices, your on-site
processing facilities, to look at what could be
65
done to minimize the food safety risks.
It encourages you to take a proactive role
in the food safety chain. It will be the first
step in the food safety chain. It has the best
advice of FDA and USDA in consultation with all
of you. The reason for the grassroots meetings
with scientists, Cooperative Extension, the
universities -- and other universities, with
anybody who is willing to provide input into that
process.
The document focuses on common elements in
growing, production, and distribution, and where
they will reduce the risk of microbial
contamination.
However, it does not contain all of the
scientific knowledge that we have or that we are
aware of, or that we know about to get everything
to answer all the questions. There are many gaps
in the science, treating manure, for example.
There has been a lot of research and work done
with municipal sewage sludges, but not as much
done with manure.
And so there's a lot of gaps in the science.
And part of this initiative is to improve the
science, to develop research, to help provide you
66
with better information for your farming
practices.
Where there's uncertainty, the guidance will
be qualified using terms like "minimize" or
"avoid" or "where feasible". And those are words
that are used in guidance. Again, somebody said
the difference between guidance and regulations;
regulations usually don't use those words, they
usually use "shall" or "may" or "do".
In this case we're saying, you want to look
at, minimize, or avoid where feasible. And
that's important because there are some times
that you cannot do that, you cannot avoid certain
things. You cannot avoid the birds flying over.
I don't know how to do that. If you invent
something, please let me know, I'll invest in it.
It is intended to provide practical advice
appropriately qualified. And appropriately
qualified means as a result of this process, of
going through the whole process of ensuring that
everybody has input.
In some areas, the guidance may properly be
more specific such as when practices are related
to federal, state, or local laws. As Martha
Roberts talked about earlier, in Florida the
67
water usage is fairly tightly controlled.
Alternate water sources may not be available to
you, so you're stuck or restricted in what you
can do based upon federal, state, or local laws.
In many cases, a packing house may come
under the Code of Federal Regulations and the
good manufacturing practices, Section 110,
because they are considered a food processing
establishment, where some are not. And that has
a lot to do with where they're located, the type
of process they're in, and so on and so forth.
And it depends, in the Code of Federal
Regulations on how they fit into that process.
Many times packing houses in the field, open
sheds where packing is done, it's gone directly
from there to the retail segment and through the
distribution chain and through the retail
segment, are not covered under that good
manufacturing practices.
Common vectors for pathogens of all fresh
produce, such as water and manure. There are
certain things that are common to growing no
matter what. And there are vectors that we know
are there. Water -- and I'm going to talk about
it in a few minutes -- is a very, common vector
68
for many, many pathogenic organisms.
On the other hand, there's also a big
difference in the size of the farms, the
regionality of farming practices, types of farms,
climate, soil differences, fertilizer sources,
employee availability, et cetera, et cetera, et
cetera.
The document will try and take into account
in being general and broad-scoped to account for
all of those things. But, again, there are some
sections that you may find in this area that do
not apply, where in other areas they do.
One of the things that I was thinking about
this morning, in the section that talks about
making sure that you restrict livestock from the
fields. And at this time of year in Oklahoma and
Texas and that part of the country, they are
grazing their cattle on the wheat fields, eating
the green tops off of them. And that's a common
practice. That's a common practice in that part
of the country, although it's not a fresh fruit
and produce, that's a common practice of letting
the cattle into the fields for the winter wheat.
Then there are cultural practices that vary
widely between different types of produce and
69
different varieties of specific types of produce.
A strawberry is not a strawberry is not a
strawberry, or a rose is a rose is a rose. How
you grow a strawberry here in Florida may be
different from the way it's grown in another part
of the country.
Martha Roberts said this morning that, for
example, many of you have already gone to drip
irrigation. Well, that's not true in other parts
of the country where they're unable to do that
for many different reasons. And so there's
different ways of doing things, even within the
same product, based upon different sections of
the country.
We want to be able to tailor it as much as
possible, but allow enough flexibility in the
document to ensure that the differences that
occur across this country can be taken into
account.
And the last question there -- I stepped
ahead too much -- is the question of why we're
here. How can we best provide practical concrete
advice to growers that will move us toward safer
produce without being unnecessarily costly to the
growers and the industry?
70
Now, that's what the guidance document is
intended to be. And how can we do that? How can
we best provide that guidance that will assist
you in ensuring the quality of the products.
Okay?
Water. Now, before we get to the actual
section, there's a couple other sections in the
document you need to be aware of.
Definitions. It talks about several
definitions. There may be some need to add some
more in there, or you can be a judge of that kind
of thing that might need to be defined a little
bit better for certain people or certain entities
in that document.
The first section is on water. And I
think -- how are we doing on the coffee? Can
you --
MS. BREWER: Ten more minutes.
MR. BARNES: Ten more minutes. Okay. Keep
talking.
Source and quality of water are extremely
important. One, because water is an inherent
source of contamination itself. Because it picks
up -- when I went to college, I learned that
water is called the universal solvent; you give
71
it enough time, it will dissolve anything, and it
will carry it with it as it goes through the
process.
And so it can pick up and become a source of
contamination itself. And you can't say because
it comes out of the water tap that it's safe
water.
If you remember the cryptosporidium outbreak
in Michigan, that's it. You've always thought,
well, if you turn the tap on, the water comes
out, it must be safe. Well, it isn't always that
way. We have to be constantly vigilant about the
water supplies that we're using to ensure that
they maintain and they stay safe. It's a very
good vehicle for spreading pathogens in the
field, during harvest, or in the packing house.
And the water you start out with may not be
contaminated, but it can become contaminated
through the process; either in the process of
washing, moving fruits or vegetables through a
flume, using water as a transportation vehicle,
cleaning the food, so on and so forth.
These are some of the organisms that can be
carried through water and have been associated
with outbreaks that are associated with different
72
types of fruits and vegetables and water
products, as well.
Because of water's potential as a source of
pathogenic microorganisms, growers should
carefully analyze their practices involving
water.
Use a lot of ground water. I just put a new
well pump in my well, and I wound up having to
chlorinate the daylights out of it to clean the
well back up again, to get the E. Coli out of my
well as a result of putting a new pump and
fooling around with it, touching it, and doing
everything else. That water was safe before, and
now it's safe again. But in between times, I had
to test it and to treat it, to make sure that it
stayed safe.
So you have to be able to look at your
practices and what you've done, what's going on,
what's happening around you involving the water
products and the water that you're using. You
want to try to seek to limit the possibility for
water-borne contamination. And that gets more
and more difficult as it goes through the
process.
Recognize the potential for water source to
73
contain pathogens. If you're using a surface
water source, is there runoff from someplace
else, are you downstream from a sewage plant, has
there been a lot of rain that has allowed runoff
from a livestock operation upstream from you. Is
there a dairy operation upstream from you where
there is a creek or a tributary that runs through
the field where the cows are pastured.
So you've got to look at what happens to the
water, and then also that it has sufficient
quality for its intended use. Using a surface
water to do the initial dirt wash off a product
that is going to then be further washed down the
road in the packing shed with a cleaner water
supply, that's the kind of process that you want
to look at. So what is its intended use. You
need to tailor it to the needs of the operation.
Now, in the document, for example, it talks
about -- I can't say it -- counter-current flow.
In other words, you want to start where the
product is supposed to be the cleanest with your
cleanest water, and if you're going to reuse that
water, like Dr. Roberts talked about this
morning, is that the water goes back towards the
beginning process so that you don't -- that you
74
use your cleanest water at the point where you
want the product to be the cleanest, and if
you're reusing that water, that it then goes --
it's reused back at a different portion, not at
the final rinse stage, for example, is one of the
ways you can do it.
And, again, the guidance does not preempt
any applicable federal, state, or local
regulations or laws or practices. You've got to
combine all of that together. Dr. Roberts said
this morning, there are plenty of regulations,
and that's true, there are. And sometimes the
regulations do what we want them to do, and
sometimes they don't.
One of the things I do other than this kind
of stuff, is I do a lot with teams and with
change. And one of the -- I believe Steven Cubby
(phonetic) said, you give a man a fish, you feed
him for a day; you teach a man to fish, you feed
him for a lifetimes.
Sometimes in the regulation business, we're
doing the former, and what we really need to do
is the latter. And sometimes this type of
document, guidance, that has the input of
everybody, does the latter.
75
Growers should consider -- don't fail me
now. So, again, do an assessment; identify and
review the source of water used on your farm. If
it's in Florida, then you're controlled by the
Department of Environmental Quality using ground
water, you still need to look at what has
happened to that ground water, what have you done
to it.
As the degree of water to produce contact
increases, so does the need for good quality
water. Again, the higher up the chain that you
get closer and closer to the consumer, the higher
the quality of water needs to be. And the review
can include determining whether the source of
water is from a well, open canal, so on and so
forth. In that process, you're going to look at
the water and what's happening to it as it gets
closer to that end product.
Now, this one; controls may include delaying
water use till the water quality improves.
That's not very practical. We realize that. But
what we want you to do is to be aware of that, be
aware of what's happening to your water so that
you can change, if necessary, do something
different.
76
Now, that may not be practical, as
Dr. Roberts said this morning. You're pretty
well controlled in the State of Florida in how
your water usage is done, but you need to look at
that process. If something does go wrong, what
are your alternatives, what kind of things can
you change in your particular operation.
Irrigation water. Again, many factors
influence the choice of an irrigation system.
Water availability and state, for example, is
what I just talked about earlier.
Cultural requirements for different types of
crops. An orchid needs a different water supply
than a strawberry or raspberries do. So in the
way that it's supplied to. Depending upon the
crop, you need to look at considering the water
delivery system that minimizes the direct water
to produce contact for certain produce, or that
that contact is far enough away from the
harvesting of the product that the likelihood of
pathogenic contamination is decreased.
Water used for crop protection sprays also
needs to be considered. Although you may say,
well, it doesn't make any difference, I'm just
mixing a pesticide with this, it's been found
77
that many pesticides mixed with the water do not
necessarily kill microorganisms that are in that
water; they're not designed to do that, so they
may survive. So the contamination could be still
there. And so the water that's used to mix crop
protection sprays also needs to be considered in
the process.
Let me catch up to my notes.
Mixing crop protection sprays. Growers need
to be sure that the water is of adequate quality
for this purpose.
Good agricultural practices to protect the
integrity of the water source. For example, if
you're using your ground water to mix a herbicide
or a pesticide, you want to be sure that, not
only is that good quality for the stuff -- the
pesticide or herbicide spray that you're going to
use to spray on the crops, but you also want to
be sure that your pesticide doesn't contaminate
your water source. There are many, many
instances around the world where someone has been
mixing pesticides or herbicides and accidentally
wound up putting it back into their water source
into the well or even into the municipal water
supply.
78
Once you get to the point where you're
using -- you're starting to wash produce, you
really need to take a better look at the water
supply to make sure it's safe and sanitary, and
that it is in a packing environment that you're
using, as you go through the process, you're
using cleaner water.
Even with sanitizers, the water might
eliminate the pathogens on the surface of the
produce, but it may not. And in some cases, the
pathogens are internalized, the wash water is not
going to do it.
When I flew in yesterday, after we came
under the clouds, I looked down, I could see a
lot of swimming pools. And I know a lot of you
know about swimming pools; this is very similar
to it; a good analogy. You put two kids in the
swimming pool and the chlorine level stays pretty
high; you put 40 kids in the swimming pool, what
happens to your chlorine level. It disappears.
The same thing is occurring when you're
washing fruits and vegetables; as you continue,
and you've lowered microbial load and it
increases in the water, even with chlorine in it,
it uses it up, and if you're not careful, if
79
you're not monitoring it, if you're not replacing
it, like an automatic system in a swimming pool
will do, the ability to kill pathogens or to
reduce them in the water goes away and becomes
virtually nothing.
There's one of the things in there that
already was commented on, on tomatoes, one of the
guidances in there was talking about washing
tomatoes with water that's ten degrees warmer
than the tomato to stop internalization of the
thing. So the growers -- many of you said, but
you don't understand, we're trying to cool the
produce and get the field heat out of it at the
same time.
And this is one of those things where we
come to you and say, here's a scientist saying,
this is a good way to keep the pathogens out of
the thing using scientific principle, and here's
a grower saying, but I've got to do something
else. Somewhere we've got to find a way that
those two come together, and that's part of,
again, why we're here.
If pathogens are not removed or inactivated,
they can spread so a significant portion of the
produce becomes contaminated. And that's, you
80
know, the old adage, the one bad apple, the
barrel of apples; same thing.
If you had one load coming out of the field
that was very highly contaminated for some
reason, and you start mixing it together in a
wash tank and washing it together, now all of
them could become contaminated if you're not
careful of what's happened with that water.
Chlorine, as Dr. Archer said, is one of the
most commonly used ones. There are some others
being used that are used in other environments,
like processing or food service environment, but
they have not been used for this type of
operation.
And again, once you get into using these
kind of things, you want to be sure that you
understand their usage, how they should be used,
and how to monitor their use during the time that
you're using it as a disinfectant.
Cooling operations. Water and ice used in
cooling should be considered a potential source
of contamination. Several food-borne illness
outbreaks have occurred as a result of ice; ice
made from an improper source or ice becoming
contaminated. It is just like a water.
81
One of the things that I deal a lot in the
retail environment, earlier this week, I said I
was working on the retail portion of the Food
Safety Initiative; we talked about many of the
same kind of things that we'll talk about later
in hygiene. You know, when people who take your
glass in a retail environment and stick it
through the ice, what have they done? Have they
contaminated the ice? Very possibly yes.
Okay. So you've got to look at that because
of outbreaks of the organisms shown here.
Growers need to be made aware of the water
source used to make ice needs to -- used for
cooling operations has to be in good sanitary
condition. But, again, it's becoming in contact
with the produce and, therefore, should not carry
pathogens to the produce, but you should do it.
Okay?
MS. BREWER: Richard? We're ready. We can
take a break now.
MR. BARNES: Okay. That's a good break.
We'll just break right here for 15 minutes.
We'll be back at 11:00 o'clock.
(Thereupon, a short recess was taken.)
MR. BARNES: We'll try and get through this
82
section of it here in about 20 minutes, do a
short question and answer, and then break for
lunch a little bit early, take an hour for lunch
and get back and then finish up this afternoon.
I'm going to try and speak a little bit
slower so that I don't wear out our
transcriptionist before lunch.
And a couple things from earlier that people
brought up. One is that, when I was talking
about water and wash water and talking about the
supply of the water, municipal supplies, potable
water supply, I did not mean to imply that, as a
grower, if you're using municipal water, you
should go test it; that should be done for you by
the entity, the municipality, the authority
providing the water to you, and they should have
the records.
So I didn't mean for -- when I was talking
about potable water, that you should be testing
water all over the place. Just be aware of your
source of water and where it comes from.
We talked about water and ice and cooling
and, finally -- and this is the very end of it --
is that, again, it's just that we want you to be
aware of the fact that water is a vehicle for
83
spreading localized contamination; that water can
carry pathogenic organisms with it, and that it
can be spread from one group of products to
another, or spread through a group of products;
that when you're using water in washing
operations, that you're aware of the potential
contamination of that water as it's being used,
and that you monitor its use throughout the
process.
Manure and sewage sludges. As I said
earlier this morning, health officials and
scientists agree that animal manure and human
fecal matter are a significant source of human
pathogens, and that untreated use of these -- use
of untreated products such as these on a product
that is not going to be further -- where the
pathogens are not going to be further reduced is
a significant risk.
The use of manure or municipal sewage sludge
in the production of produce must be closely
managed to limit potential for pathogen
contamination of produce.
Now, we know that -- and I'll talk about it
in a minute -- that there are not a lot of use of
municipal sewage sludge so much in the farming
84
community, but that it has been used. And where
I come from and was working in Oklahoma, every
spring, one of the places we went to get the best
tomato plants was at the city municipal sewage
sludge plant, because they were grown in the
drying beds and they had beautiful tomato plants
that got about that high that you could take home
and plant and grow nice tomatoes.
So it is being used, and there is more
research has been done on municipal sewage sludge
than on a lot of manure products. So there is
some evidence of its use. They know that this is
a good soil conditioner and that properly treated
sewage sludge that has pathogens reduced and does
not have heavy metals in it -- which is one of
the other things that they definitely look at --
municipal sewage sludges is a good soil
conditioner and fertilizer.
You've got to be alert to the presence of
human or animal fecal matter that may be
introduced into the produce growing and handling
environment. The use of manures, whether it's
chicken or other type of animal manure, is used
in the environments. And, again, it talks about
in the document, site packing, for example, and
85
so on. You've got to be aware of that process.
Properly treated manure or municipal sewage
sludge is a safe and effective fertilizer. But
untreated or improperly treated manure could
contain pathogens that eventually would get into
the produce and contaminate the produce.
And, for example, with some produce, leafy
produces like lettuces or whatever, if it was
contaminated, it may be very difficult, then, to
wash that product or to eliminate the pathogenic
organism from it before it goes on through the
food safety chain.
Although municipal sewage sludge is not
widely used on fields growing fresh produce,
there is a lot of information about its use and
where it has been used, and it does, again, serve
as a source -- untreated sludge serves as a
source of contamination for produce.
Again, the sources of fecal contamination,
untreated or improperly treated manure, nearby
composting or treatment operations, nearby
livestock or poultry operations, municipal
wastewater storage or disposal areas, you know,
if you have a produce field very close to a
municipal sewage plant and something happens
86
because of a rain or whatever and they have to
bypass, even though that's their -- with all the
requirements they have, if that happens, if they
bypass and it gets into your field, you need to
be aware, if that happened, the possibility of
contamination of produce.
And then, finally, the last one, high
concentrations of wildlife in growing areas. We
were talking during the break about some of the
things Dr. Archer talked about, covering ponds.
And, again, those -- that's not a thing, but
covering tanks might be a better analogy.
We would not ask -- and I was telling them
in Maryland, the deer we have, I don't care how
you build a fence, if the deer want in, they're
going to eventually get there to your garden. So
that's not -- again, it's looking at what's
around you; what types of contamination can
occur.
And Dr. Roberts was talking about, saying,
you know, putting in a produce growing area
downhill from a cattle operation is not -- would
not be considered really good practice and
should -- and would be the kind of thing we're
looking at.
87
Growers need to develop and follow good
agricultural practices for handling manure to
reduce the potential of introducing microbial
hazards of produce. And this talks about
different practices; processes such as composting
to reduce the levels of pathogens, minimizing
direct or indirect manure-to-product contact, and
assessing adjacent or nearby land to determine
the risk that it may pose as a result of water
runoff, wind blowing, and so on and so forth.
Some of the treatments to reduce pathogens
in manure; passive, nature and time. There is a
competition that occurs with the soil
microorganisms that have a tendency to overwhelm
the pathogenic organisms when it's tilled in and
it is allowed to sit for a period of time.
Active types of things, like pasteurization,
anaerobic digestion, aerobic digestion, et
cetera.
Composting divides it again, which most of
you are probably aware of, what it is and how it
helps to make the manure safer, reduce the
pathogenic or the organism level in the manure so
that it can be used as a safe amendment.
And some of the science is there, some of it
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is not. The NCRS has some data on composting,
they have some booklets on composting we can use,
talks about some of these things that have been
done with EPA and municipal sewage sludge, two or
three days at 131 degrees, I think it is, I can't
remember what the exact temperature was. It
talks about they know that that will reduce the
thing, but some of it for manure is not known.
And, again, how you compost manure here in
Florida is going to be a lot different in
December than how you compost manure in North
Dakota, so there's a big difference in how that
works.
We don't have the data to tell you all the
time and temperature recommendations. In one of
the statements in there, it talks about -- maybe
one of my next slides -- of putting it on the
soil so many days ahead of time then leaving it,
and these are minimum amounts of time. And
there's one of them, it talks about 120 days.
And there's not really the science to support
that yet, but it's a recommendation.
Again, it will vary, depending upon whether
you're using treat or untreated manure. And,
again, here's a -- the growers may reduce the
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risk of contamination from manure by maximizing
the time between application and harvest.
The minimums range from 40 to 60 days, but
some recommendations are 120 days or longer. And
that's a recommendation; that's not always -- and
that's part of the research process that's going
to go on under this initiative, is to look at
those kind of things to determine and to give you
better data on what kinds of things you need to
do, what kind of operations need to take place,
moving the product from outside in, et cetera, et
cetera, et cetera.
Natural fertilizer, such as composted manure
have to be produced in a manner to reduce the
likelihood of introducing microbial hazards. And
there's many questions about that. If it's been
produced in a composting facility, it gets to you
and you store it outside for a while, is it
possible for microbes to get to grow or to be
reintroduced into the composted or treated manure
for fertilizer.
So how it's handled and what happens to it
after it's been treated may have an impact, and
there's some of that information that is not
available.
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Cross-contamination which could occur as a
result of your composting operation from stuff
being wind-blown or runoff from it going downhill
into your field where you're growing the produce.
Depends on, again, looking at the process, how
and where it's being done, is there any
likelihood of contamination occurring in that
process.
And, again, there's some -- not a clear
indication that composting or other treatments
totally eliminate the pathogens. In many cases,
you're not talking about a sterile product. It's
been reduced to a low enough level, but it's not
a sterilized product. If you were going to buy
sterilized manure, that's one thing, but if you
just composted it, it may reduce the pathogens.
But, again, in some of the organisms that
have been seen, the levels that were required to
cause food-borne illness may be very, very low.
So even though we reduce them to a very low
level, it may not be enough to eliminate the
possibility of contamination of the final
product.
So you want to consider even treated manure
under the same aspect that you might untreated
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manure, being sure there's a long enough period
of time, even after you applied treated manure to
the product before harvesting is similarly to
what you would do for untreated manure.
Again, here it talks about cross-
contamination runoff, leaching from wind spread
from your composting operation or your manure
handling operation.
We're going to go on now and talk a little
bit about sanitation and hygiene and microbial
hazards associated with workers and people who
are working in the field.
The worker health and hygiene do play a
critical role in the controls to minimize
microbial contamination of fresh produce. The
fecal oral route is the majority of the way that
many of these pathogenic organisms affect people.
That is how it occurs; that's where the
organism is shed, from the human body, a person
who is ill, and can wind up on the hands or
something else, and wind up back in the mouth of
another person.
And so the fecal oral route is the primary
microbial concern with most of the organisms
we're talking about.
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Good hygienic practices by workers are
essential in the control of microbial hazards.
And, again, as I had talked to you earlier or
showed you earlier the other document from farm
to table, that's part of the essential thing all
the way through to the consumers.
All of the educational campaigns, all of the
documents that you see from the entire Food
Safety Initiative reemphasize this, that good
hygienic practices from the farm all the way
through the housewife or house-husband at home
preparing the meal are necessary in order to
avoid the contamination of the food products.
People who are ill, who are working in any
part of the food safety chain, whether it's in
the field, picking produce, packing it,
distributing it, processing it, serving it,
retail to the consumer, anywhere along that line,
it's possible that it can become contaminated and
wind up causing illness.
What we would like -- and in the document it
talks about -- is to control those hazards in the
growing environment. Employees tell -- or report
to the person who's in charge about their health
as they go -- as they're working, to talk about
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diseases that they understand and have some
education or are talked to about the diseases
that are transmissible through food that they may
carry, that they could contaminate the food
product with. That the people in charge should
be aware of the health of their employees,
wherever possible. And that individuals with
diarrheal disease shouldn't be handling directly
fresh produce.
Now, we realize that you could certainly not
say to the farm worker, or the person working in
the shed, if you're sick, we can't let you work.
Their livelihood is just the same thing we deal
with in the restaurant; they are paid for the
time that they're there. But what we have done
in the other environments is look at what other
kinds of tasks can that person perform without
actually having their hand on the food product
itself. Could they drive a truck, could they
clean and maintain equipment that day, could they
work at -- I should say work in the manure pile,
that's not -- are there other things that they
can do other than actually putting their hand on
the produce during times that they're ill that
might minimize their contact with it.
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All the employees who are involved in the
harvesting, packing, and distribution of fresh
produce should be trained in good hygienic
practices. I can tell you from my long
experience in hand washing, without getting up on
my soap box, that a great percentage of the
people in this country do not wash their hand
after they go to the bathroom. And that's not
out only in the fields; that's every day, every
place you go. If you don't believe me, next time
you go out to the theater, you go somewhere out
to dinner or whatever and you go to a public
restroom, take a minute and look and see; look
and see how many people come in and go out, and
the only thing they stop at the sinks and the
mirror for is to check their hair.
Consider establishing a training program. A
good training program would cover -- a part of it
would cover hygienic practices. Also, it might
be part of a total program where you look at all
the other things that are necessary for you as an
operator or producer in the field.
A system to monitor. How can you be sure
that the people that are working in your packing
shed, after they have gone to the little green
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building out back, have washed their hands before
they come back in and sort produce or chop it or
put it in plastic bags. They need to be taught
proper hand washing techniques.
Wherever possible, you'd like them to use
warm water and soap. But any water and soap --
any potable water and soap is going to remove
contamination from their hands, especially after
something that talks about things in the thing,
after smoking and eating, after going to the rest
room, which is very, very important, after being
out -- let's say that they did work in the
morning, working shoveling or working at the
composting pile with manure, moving the outer
layer into the center. Then in the afternoon
they're coming and helping with the harvest. You
want to be sure that they have not caused any
cross-contamination, that they've washed their
hands.
On-site latrines and elimination of wastes
outside of these facilities with some kind of a
good toilet facility needs to be ensured. There
has to be a way for people to eliminate waste
from their body in a safe and sanitary manner
that is not going to cause pollution or
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contamination of the environment or the produce.
Toilet facilities, the proximity and
accessibility for harvest crews is important. If
you're harvesting a section of land and you've
got one port-a-potty that's at the opposite
corner of it, is it accessible to the employees
or are they not going to make it all the way over
there on their way.
So you need to look at where they're
located, that you have enough facilities for the
number of people that are working, and that
workers have the opportunity to use the
facilities when needed.
Assure that the location of facilities is
not near a water source that's used in irrigation
or that there's any way that contamination from
that should it overflow or gets blown over, it
leaks, whatever is going to contaminate water
source, the produce itself, equipment that might
be used out in the field, so that there's no way
that runoff or anything else is going to
contaminate the product.
Again, hand washing stations, it's very
important, especially after using the rest room,
anybody with diarrheal disease should be suspect
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and should be looked at as a possibility of
carrying or shedding the pathogenic organisms,
and that's a call that you're going to have to
look at and do, but the idea of having toilet
paper, the ability to wash and dry their hands is
going to make a lot of difference.
Service the portable toilets away from the
field, if possible. If not, to be sure that the
truck that services it can get into the field and
close to it without contaminating anything. If a
spillage should occur from the truck, that it
doesn't wind up all over your produce, et cetera.
Make sure the drainage is correct. If something
does go wrong, that it's disposed of away from
the produce or the packing shed or whatever other
facility you're using.
A little bit different. This is the
harvesting precaution itself for the product.
Wherever possible, get as much dirt, mud, et
cetera, off the produce while in the field. What
you're talking about here -- or what we're
talking about is eliminating as much
contamination as possible before it gets into the
packing shed, before it gets into the
transportation system, before it gets into the
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packing boxes, et cetera.
Somebody said -- we talked about muddy
cartons or pallets, using them to stand in in the
field while they are harvesting, standing on the
pallets or standing in the cartons that the
produce is going to be packed in while they're
filling one, and then stepping out of it, and
then using that one, then, to fill the produce.
Those kind of things need to be looked at during
the harvesting operation to be sure that there
isn't cross-contamination or contamination of the
vehicles that transport the produce.
If it's packaged in the field, make sure to
look at the contamination process -- or that it
isn't contaminated and being carried through the
system. Inspectors, anybody else who is handling
the produce, sorting it, grading it, whatever
they're doing with that product, that they also
have good hygienic practices; that they're
washing their hands or using some other method of
ensuring that they don't contaminate the produce
themselves.
Equipment maintenance. Now we're talking
about field equipment. Maintaining equipment
sanitation. Now that word sanitation does not
99
mean sanitizing. And that just means the ability
to remove gross dirt, et cetera, from the
harvesting or the equipment that's used in the
production process or the harvesting process.
That may be everything from harvesters to
tools, et cetera, et cetera, that need to be
cleaned on an occasional or regular basis to
ensure that they don't add to or contribute to
the contamination of the final product.
You certainly are well aware you're not
going to use a manure spreader to hall lettuce
back to the packing shed, but the other pieces of
equipment need to be looked at as well for gross
contamination. If that farm wagon that's towed
behind the tractor happened to go through the
field that you just applied untreated manure to,
and you're not going to produce, there's a
possibility that it's going to carry some of that
back into your produce field.
Again, you're going to look at the whole
facility so that anything in the process from
harvest through processing that makes contact
with the produce is cleaned and is not going to
add or contribute to the contamination of that
product.
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Poor sanitation in the packing house can
increase the risk of contamination of the produce
and the water supplies that are used in that
environment that are used with the product.
Again, closed packing houses in many cases
that are permanent facilities may be covered
under the Code of Federal Regulations, Part 110,
Good Manufacturing Produces, and the water and a
lot of the cleanliness and the equipment types
and so on that are used in that facility are
going to be different from the ones that are used
in an open packing shed out in the field.
Equipment that is used in the packing
process or in the processing facility, knives,
saw blades, et cetera, et cetera, need to be
inspected and cleaned on a regular basis. Again,
it goes back to the same thing we've been talking
about all along, anything where there's a
possibility of adding to or putting contamination
into the product needs to be looked at and cared
for in the proper manner.
Pest control. Here, we're talking about
primarily in a closed facility; a closed packing
house, not an open packing shed. You want to be
sure that animals are excluded, that maybe it's a
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source of contamination. So there are many
things that can be done even around open packing
sheds that eliminate or reduce the risk of insect
or rodents, birds, et cetera from being in that
environment. Not giving them harborage, places
to hide, to nest, those kind of things.
So those things you just need to look at to
try to keep the processing facility, the packing
house and the grounds around them in good
condition so that they don't become a vector for
contamination.
And then there's transportation. Now that
we've got it out of the field, it's been in your
packing house, it's put in the packages, the
crates, the pallets, whatever the method of
transportation is, now it gets -- starts it
through the food safety chain moving up towards
final consumption. And this is a part that you
also need to be aware of.
The people who transport your food products,
what kind of vehicles are they using. You're
certainly not going to be putting your crates of
lettuce into a cattle hauler for him to take back
because he hauled cattle down here and now he's
going back to somewhere up north, he's going to
102
hall your lettuce back.
You want to be sure that the vehicle that is
being used to transport your product that you
spent so much time and effort on to ensure it's
free from contamination doesn't add to the
contamination at that point in time.
Cross-contamination with other foods and
non-food surfaces can occur during transport.
There's a DOT law that was passed many years ago,
most of you are aware of, called -- regarding the
back-hauling of hazardous waste products, the
back-hauling of food products after hazard waste
and those type of things were hauled in vehicles,
to ensure that that doesn't occur.
But that doesn't cover other kinds of things
that might be in vehicles. So you need to be
aware of what might happen during the transport
of your product to ensure there's segregation
from other types of food that might contaminate
your produce and to ensure that the carrier has
met some kind of sanitation requirements; the
truck has been washed out, been swept out, that
the -- there's no leftovers from the previous
cargo that's carried in that that could lead to
or cause a problem with your product.
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And, again, this is a communication problem.
Make sure that all along that way, that you're
aware of what's happening to your product while
still under your control.
And traceback -- and, again, we're calling
this, really, positive lot identification instead
of traceback. Traceback is the process that we
go through when we look back to find -- an
epidemiologist goes back, a health professional
goes back to try to find out the cause of the
food-borne outbreak.
Positive lot identification is the ability
to identify those lots. And this becomes very
difficult. It is very difficult to do this and,
we realize that, and that's why it's here,
because we need your suggestions. We realize
that after it leaves your facility, your packing
house and it goes to a distributor, it may be
commingled or that, in some instances where it's
going directly from your field to someone who is
packaging the product who bought the product from
you, they commingle it with products from many
other farms.
And so positive lot identification is a
problem, but we need your input into how we could
104
better do that. How could we better identify the
products coming from anywhere so that they could
be followed back so we know where they came from
so we could determine how the contamination is
occurring and stop it.
Again, traceback won't prevent a hazard, but
it can limit the potential scope of an outbreak,
limit the populations at risk, lead to specific
sources or fields, lessen the economic burden on
the operators and on the growers, limit the
economic burden on specific products.
In talking to the gentleman earlier about
the impact that -- somebody saying this caused an
outbreak or that caused an outbreak, it happened
in the whole industry; we've seen that over and
over again. We know that that happens.
We've seen it with hamburger chains who did
not have contaminated hamburgers, or even have
meat product in their thing, but because they had
a hamburger, they felt the impact of it. So we
see that all the way through the industry.
Again, positive lot identification minimizes
the unnecessary expenditure of public health
resources, reduces consumer anxiety, and that the
operators have procedures to trace it back from
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the farm to receiver and so on.
If there's any things that -- ideas that you
have to help us with that process, to talk about
how we can better identify the lots, that's
information we're interested in.
And this just talks a little about traceback
and the type of things that are needed in order
to follow a product back to its roots.
And that's a very brief, very general
overview of the guide. Let me put the lights on.
Wake up.
With that, it's about 11:30; why don't we
have a few minutes of questions about the
presentation, if you've got any questions that we
can answer quickly, and then we will break for
lunch.
So does anybody have any questions this
morning or are we just ready for lunch?
DR. ARCHER: Doug Archer, University of
Florida. I just had a quick question because I
came across it when I was reading the guidelines.
What is the perceived risk for open lesions?
I mean, I know aesthetically it's not fun to
think about eating blood, but what's the risk?
What's the microbial risk?
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MR. TROXELL: The ongoing infection and
spreading that in -- the infectious materials
into the produce.
DR. ARCHER: I mean, usually we think of
staphylococcus, you know, as the risk from an
open lesion.
I'm not aware of a single outbreak of staph
food poisoning from fruit and vegetables, and I
think there's a good reason for that
physiologically.
But what other kind of infectious -- I'm not
aware of any food-borne infectious material that
gets passed along from a lesion. That was my
question.
MR. TROXELL: Okay.
DR. ARCHER: And I guess the other one I was
curious about, there's a lot of detail on hand
washing procedures for people that are working in
the growing field.
What about people in the grocery store?
MR. BARNES: There -- and I talked this
morning about the total continuum of this farm to
table.
DR. ARCHER: No, I mean a consumer.
Probably they fondle produce a whole lot more
107
than the people --
MR. BARNES: The -- again, the Fight BAC
campaign, one of the things it talks about is
specifically that, is geared towards the
consumer.
The food code, that covers a whole segment
of the retail industry, goes into great detail on
hand washing and the necessity for that and the
GMPs and the processing and the manufacturing
environment, which is probably better controlled
there than in many places, it goes with that
there.
This is the final piece. Again, this is the
farm to table continuum, and your comment about
the -- other than Staph aureus from an open
lesion, again, that may not be a significant
factor in the field, but it is part of the
continuum. If we continue to talk with the same
message all the way from farm to table, the
message gets through.
Anything else?
DR. ZAWEL: Stacey Zawel from the United
Fresh Fruit & Vegetable Association.
Terry, I had a question for you regarding a
specific statement in the document, and I know
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this has been mentioned over and over in the
sense of the impracticality of this specific
recommendation which is in 1.1 under irrigation
where it says to cover open reservoirs.
I never asked the question and so now I'm
going to ask you the question. In the context of
developing some of these ideas or things that a
grower could institute to impact public health,
what is it that was envisioned here?
MR. TROXELL: Covering open reservoirs was
an earlier draft. Is it in this -- I mean, I
thought we pulled it out.
MR. BARNES: Yes, it still is.
MR. TROXELL: It is? Well, it shouldn't be
there.
DR. ZAWEL: Okay.
MR. TROXELL: And it was supposed to be
changed to being a -- protecting your --
basically, your water shed. And that's the kind
of thing you can have some impact on. But --
DR. ZAWEL: Okay.
MR. TROXELL: -- covering reservoirs doesn't
work.
DR. ZAWEL: Thank you.
The other statement that I wanted to make or
109
follow with a question is that, the United Fresh
Fruit & Vegetable Association represents growers
all across the United States as well as in other
countries and, in fact, many of our growers
domestically also grow in other countries.
And so given that, it's important for us to
take a position that we need to encourage the
appropriate food safety measures no matter where
we're growing, and I think that the industry
domestically has certainly shown a tremendous
amount of leadership in that area, and now the
federal government is also doing the same thing.
But along that line -- obviously, it's going
to be very important how that gets implemented so
it doesn't impact a domestic grower.
And along that line, though, the WTO is
undertaking this, and CODEX has, in fact,
directed, at the last food and hygiene committee
meeting, directed Canada, or a Canada volunteer
to draft guidance in this area for cold produce,
and France had also volunteered to draft guidance
for fresh-cut, and I'm wondering how this is all
going to fit together, or if it does.
MR. BARNES: To answer that, yes. And in my
notes, which I kind of couldn't see all of them
110
that are written down, but I had -- in the
beginning of it, I want to talk that this was
designed to be consistent with WTO and with GATT
and with other things as well.
And so that -- that -- I didn't say that,
but that fits into what you're saying, is that we
don't want this to be inconsistent with any of
those things, nor do we want to develop something
that -- reinvent the wheel, I guess is the best
way to put it.
So those things, we hope, will be
incorporated as we go through the process.
DR. ZAWEL: So you --
MR. VANDERVEEN: Well, let me just make the
comment that in order to deal with CODEX, we have
to have a position. And to get out in front of
it is a lot better than trying to react to what
someone else is writing. And a quick reaction is
also good.
So if we can get our heads together and come
up with what we think is a good guidance, and
there's general agreement with it, we can respond
to whatever drafts that come around.
And let me just say, also, we're trying
desperately that when a CODEX document does get
111
out, we want public comment on that, as well.
But I think we ought to have our discussions
amongst ourselves long before CODEX gets to the
point of having a final draft.
MR. TROXELL: Let me add, also, that, as you
recall in the public meeting on the 17th, Stacey,
I acknowledged and commended the industry for the
work that they've already accomplished in this
area and, you know, the work that's been done has
been well articulated and efforts to implement it
have been well done, and I think it's going to
help us come up with a good document that -- you
know, we can put out as a -- as something for
both domestic and imports to work with. I think
it's going to help us come out with something a
lot quicker and it will be a better document,
so --
DR. ZAWEL: And one sec.
I guess my concern is that -- or not
necessarily concern, but my hope would be -- and
I know Canada has talked to the FDA -- is that
this document be perhaps a model wherever, that
we, the U.S., takes a role and works closely with
Canada in the development, and I think you're
already doing that. But rather than having two
112
separate initiatives for U.S. growers, that could
be part of developing equivalent standards for
the U.S. -- for the world.
MR. TROXELL: And the process we have
outlined is inviting everybody to participate.
We're going out of our way to solicit input from
every major producing region in the U.S. and
trying to solicit input internationally, that's
why we're holding an international meeting and
hoping we will be able to come up with something
that will be a template for the CODEX, will be
able to show some leadership here, and I don't
think with the way things are -- the status of
the situation, that we really can wait for two,
three, four years for CODEX to come to agreement
on something.
MR. BARNES: Yes?
MR. STUART: My name is Mike Stuart, I'm
with Florida Fruit & Vegetable Association, and
this is a question for any one of you up on the
panel.
We've been hearing a lot that -- through
this process about the importance of making sure
that this guidance document is consistent with
the WTO, and I guess that's fine.
113
But I guess my concern is, what efforts are
we taking to ensure that the guidance is
consistent with existing state, federal, and
local laws and regulations?
We've got, obviously, a very complex set of
rules and regulations that apply to this
industry, not just here in Florida, but
throughout the United States, and to the degree
that there may be provisions in it -- we've
already talked about some of the irrigation
issues, but I think there are some of the issues
regarding worker reporting and that type of thing
that may perhaps apply in the face of either
local or state regulations or even federal laws
and regulations that would apply to that specific
area.
What are you doing from an inner-agency
process to ensure that we're being consistent and
not providing guidance to an industry that might
be encouraging them to get into some gray areas
of other laws that they're already required to
comply with?
MR. TROXELL: We -- this is a very --
obviously, a very complex agricultural system,
and the requirements across the country vary
114
tremendously.
This document probably does not say it
strong enough, or say it at all yet, as a matter
of fact, but the recommendations here, the
advice, the -- to minimize this, when feasible,
et cetera, that's in here, has to be like that
because of the great variety of the situations
across the country.
But we need to make it very clear in here
that this does not substitute or replace any
state or local requirements, and we will do that.
This is not to undermine in any way --
MR. STUART: I guess the reason for the
question, I don't want to see producers in the
United States, anywhere in the United States,
Florida in particular, finding themselves in a
situation where they're having to deal with their
buyers in the marketplace because they want them
to comply with the particular items found in this
guidance, and then having that particular
provision, whatever it happened to be, put them
in some gray area against state or federal law or
regulation on that specific area. I think that's
extremely important that you don't put producers
in that predicament.
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MR. TROXELL: And we agree, and if there's
items in this document that cause such problems,
we need to know about those items.
MR. BARNES: And there are several sections
in there involved, that Terry said, that already
talked about applicable -- I think a couple of my
slides showed that where the applicable guidance
may come from federal, state, or local laws
that -- first, and these may supplement it a
little. But that those existing laws are what
need to be followed.
This is a guidance document, again. And
maybe we need to put that in each chapter, but I
know it's in there in several places.
DR. ROBERTS: May I be permitted to ask a
question, too?
MR. BARNES: Certainly.
DR. ROBERTS: Along that very same line, I
know there's been a lot of discussion, even in
the room today, as to how best can FDA state
within the document that these should not become
de facto regulations at this very moment, you
know, with buyers insisting that people meet a
certain specific suggestion within your proposal.
MR. TROXELL: Well that, of course, is
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always a risk that guidance or advisories will
become, effectively, requirements through
contracts by your grocery stores or your food
service establishments and so on.
The only thing we can really do there is
emphasize that this is guidance; it's not
regulatory, it's not binding. And the other
thing I think that helps that situation is, in
the document we talk about minimize, avoid to the
extent feasible, you know, if practical, and so
on, and it's very difficult to take those terms,
which are -- to take those terms and convert them
into something that becomes a requirement.
I mean, because if you say avoid to the
extent feasible, well, okay, that's a matter of
degree, and people can avoid to the extent
feasible to different degrees.
MR. VANDERVEEN: I think, Martha, you do
bring out a good point, and I think we'll go back
and, maybe you want to put on the front of this
document as draft. It's clearly a draft at this
point in time; it is a working draft, and we
probably have been a little hasty in not labeling
it as such.
MR. BARNES: It is labeled at the bottom in
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little letters.
MR. VANDERVEEN: Oh, yeah. It says working
draft down in the bottom. You might want to put
that in great, big letters at the top, especially
if you're --
MR. TROXELL: We would clearly like to hear
your ideas and how we can cast this to help avoid
the problem of this becoming a requirement
through contracts.
MR. VANDERVEEN: Well, the question of when
it's a final document, if someone wants to use it
in that manner and they have good reason to do
it, then that's reasonable. But we do have
that -- we recognize that that is an issue.
MR. BARNES: We've got -- how about two more
questions and then we'll break for lunch. And
we'll start in the back, you were up there first,
please.
MR. MATTHEW: Good morning. My name's
Charlie Matthew, I'm with Florida Fruit &
Vegetable Association.
In the guidance you've dedicated an entire
section to crop protection sprays. And my
question is, what information and data do you
have that would show this much significance to
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crop protection sprays?
MR. TROXELL: I don't think -- well, there's
no intention by the amount of words to indicate
the weight of the problem. I think we just need
to use as much -- put as much information in
there as necessary to assure that the correct
practices are taken.
I don't know that this is a very serious
problem, but it's something that we have to
recognize and make recommendations to deal with.
MR. MATTHEW: And I agree with you, that
there possibly could be perhaps the potential.
But my question is, you know, you've
dedicated an entire section to the importance of
this, and I don't understand -- and what are the
instances where you can document that applying
pesticides had resulted in problems, you know,
microbial problems?
MR. TROXELL: Okay.
MR. MATTHEW: And following along with
that -- and I don't handle this -- but you're
using language like "should" and "verify", that I
don't know, perhaps we should be using -- should
be using verification and other things that other
places that are perhaps more important than
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something where we really don't, to my knowledge,
have a documented occurrence of a problem.
DR. ROBERTS: Terry, if I might on that --
MR. BARNES: Thank you.
DR. ROBERTS: -- earlier point, you know,
again, we have a whole section in there, and to
my reading and recollection, the only instance
you ever show where that might be a problem is in
your investigation of the Guatemalan raspberry
situation, and some of the documents that you put
out there about a situation in a foreign country,
you were then -- the description of what you
found said that that was a potential problem in a
foreign country on the Guatemalan raspberries and
cyclospora.
But I've never seen a documented mention for
a domestic situation. There may be some that I
don't know about.
MR. TROXELL: But this document is for
domestic and foreign produce production.
DR. ROBERTS: Okay.
MR. BARNES: One more question, and then
we'll go to lunch.
DR. BEASLEY: Terry, I'm going to put you on
the spot, I guess, because basically -- my name's
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Larry Beasley and I'm with A. Duda & Sons. We
grow about 40,000 acres of vegetables and a
little bit of citrus and I'm quite concerned
about your guidance document.
We're talking about perception of a
perceived problem, and we're talking about
liability.
Mike Chappell, John Vanderveen, Martha, you
brought up the subject of guidance, Richard
Barnes, you brought up the subject of guidance.
I'd like to point out to you, there's a
buyer here from Kroger, and he's drafting his
letter now to his buyers with the tick marks on
it based on your guidance document, telling us
what we will or won't do, and what they will
consider that we have to have in place in order
for them to purchase from us.
This is not guidance. Guidance is only one
step in the evolution of a regulation, and I
don't care what you write in fine print or bold
print on your document; this is a regulation. No
question. Point made.
MS. ISAACS: Okay. Enjoy your lunch and
please be back one hour from the time you
currently have on your watch.
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- - -
(Thereupon, a lunch recess was taken.)
- - -
(Thereupon, the Public Hearing resumed at
1:05 p.m.)
MS. ISAACS: This afternoon we're going to
begin with the role of the USDA and our presenter
is Dr. Ricardo Gomez.
Ricardo is the principal horticulturist with
Cooperative State Research Education and
Extension Service, USDA.
Is that Washington, I take it?
DR. GOMEZ: Yes.
MS. ISAACS: Washington, D. C.
Okay. So he's going to discuss the role of
USDA.
DR. GOMEZ: Thank you. Before I start on
the role of USDA, which is somewhat complex, I
wanted to thank Clayton. I think his offering
this facility to us has been fantastic.
Clayton and I, by the way, went to school --
talking about a communications -- went to school
at the University of Florida in the late '60s,
'68, nine and so on. Both in the same department
of fruit crops, and we didn't know each other.
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But I had talked to Clayton about six, seven
years ago, Clayton? So we sort of know each
other a little bit. But thanks. The facility's
great.
The role of USDA. We are an extremely
complex department; we have several roles. We
have regulatory roles, outreach, and education
roles. And in this initiative, I think we can
take advantage of all those three roles that the
department offers.
As you all know -- or if you don't, I'll
tell you -- there are some regulatory agencies
within the department. The Food Safety
Inspection Service is that which is responsible
for meat and poultry inspections in the U.S. and
foreign lands.
The Animal and Plant Health Inspection
Service is also one that has point of entry
responsibilities to keep agriculture safe,
American agriculture safe from foreign pests.
These two agencies can really be a lot of help in
having also outreach capabilities in those
foreign areas, as well as within the U.S.
The foreign agricultural service, through
its international cooperation and development
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activities and the scientific exchange programs
also has a major role that it can play in here.
But getting closer to the initiative itself
is the national agricultural statistical service
which has working relationships with the
departments of agriculture in all -- in all of
the 50 states working with the State Agricultural
Statistical Services.
And they're the ones that survey -- do
surveys on our farms -- statistical and valid
surveys, by the way -- to get information on
crops, pesticides and so on. And I think we've
been talking to them in this initiative about
trying to include, as part of their surveys, some
questions that may be applicable to this
initiative so that we get some valid feedback
from them. So that's one agency that we are
dealing with as a part of this initiative.
There's two or three other agencies, the
Agricultural Research Service, which is the
intramural research agency of the department.
And this agency serves the -- both the regulatory
agencies as part of the research programs and
other agricultural research of probably more
basic type than the other agency which I belong,
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which is the Cooperative State Research Education
and Extension Service. That one is really the
federal department.
And here's the first time I'm using the word
partner; it's a federal partner of the
Agricultural Extension Service and the
Agricultural Experiment Station System.
So our agency and ARS are those that do the
research. And we will be, as we identify some
knowledge gaps -- and these are not good
agricultural practice; holes in our knowledge --
that we will be putting into motion some
research.
And as was stated before, I think Richard
said that we're not -- we do not have monies in
the FY98 budget for this, but there are some
funds that have been requested for the fiscal
year '99 and beyond. So there may be some monies
available to do some research on specific aspects
of this initiative later on.
One other agency, as well as ours that has
routes or branches down to the local level is the
Natural Resources and Conservation Service. The
Extension System and NRCS, as well as the
partners in the Soil and Water Conservation
125
District, really touch the producer, him or
herself. And those are the agencies that will
really be involved in the outreach and
educational programs through this initiative for
the Department of Agriculture.
I think that partnership that we have with
NRCS, with ARS, with our local Extension System,
is really the foundation that this initiative
needs to look at to go forward and be functional.
As has been stated before by many of you,
the initiative needs to be based on good science,
but we don't have all the science. We need to
identify those gaps, those knowledge holes, and
start working on them very quickly.
I know ARS has already made some changes in
funding directions and they are working, or
starting to gear up to work on some of the
composting questions that have arisen within this
short period of time that we have been working
on.
So there are possibilities, not only of
additional funding, but also of redirection.
Redirection is good and it works in a straight
line agency. And that's another point that I
want to stress to you, is that both the
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Experiment Station System and the Extension
System are partners with my agency, but we're not
a straight line agency. God forbid me if I tell
Clayton, as a federal guy, to do something
because I fear what he's going to tell me back;
really fear it.
So we have a good relationship, but we are
partners. As a matter of fact, the federal
branch is a minor partner in the Extension
System. We only fund about 30 percent of the
whole extension deal, whereas the state and local
levels fund the rest. So we are a minor partner,
but we can be -- we can be very successful,
especially if there's some additional money.
So let me give you an example or two of some
of the other -- some of the things that we have
done as partners.
We have a program that is called the
Pharmacist Program, which was borne by the
federal agencies, NRCS and CSREES, working with
the land grant institutions to develop a
management tool for producers mainly to do with
the environmental consequences of agricultural
practices, but looking at it from an economic
point of view.
127
And I think I need to stress the point,
economic point of view. If an initiative is
going to work, it needs to be based on sound
economics; nobody should really take a bath
trying to follow any of these guidance documents.
We need to develop the guidance documents
with common sense, based on science, and based on
economic reality.
The Pharmacist Program has been very
successful, and Michigan State University and
several other institutions are already working to
incorporate into that pharmacist -- which is a
computer driven program, but nonetheless, it's a
good program -- they're starting to put in some
of these food safety and quality aspects into
that.
But it still leaves the ultimate decision in
the hands of the producer. It does not take away
the management aptitudes.
Another program in which NRCS and Extension
have been working very closely in is the water
quality. And we have, in each and every state,
just about, some water -- water shed management
projects that have shown us some of the real
practices that will deter runoff, that will deter
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pesticide contamination of waters and so on. And
I think these two models -- and there are many
others, by the way -- but these two models are
based on science, they are based on common sense,
and they are not pushing the economic picture out
of the way.
They are based on economics; on good
economics, so there's some profit still available
to the producer.
It is also a voluntary type program at this
point in time, even though some of the farm
management plans that NRCS has responsibilities
for require certain management tools or practices
incorporated. But it's still a -- they're still
voluntary, if you participate in a USDA farm
program, then you have to have a management plan.
The voluntary aspect, the good science and
so on, are what make these type of programs work.
We do not take the producer and make him a slave.
We let him or her manage that production
facility.
We also have, in the CSREES, in my agency,
other programs that really need, and could be
very useful to this initiative, and we're
bringing all these things in. Even though today
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it may not appear the USDA has a vital role in
this initiative, we do. Believe it.
And as the guidance documents continue to
develop, we will have more. You need to remember
that FDA is not a non-agricultural based agency,
whereas the USDA is an agricultural based agency.
So we need to be complementary.
But other programs in which my agency can
help with are the Expanded Food and Nutrition
Program, which also addresses the consumer issues
associated with this initiative. And there are
some. It's not only the responsibility of the
producer to manage the output of fresh fruits and
vegetables to be -- to increase the microbial
contamination; it's throughout the food chain up
to the consumer.
That's the responsibility of us as people,
as consumers, also. We have that. We are also
involved, and the department is greatly involved,
in the food stamp program. These are all
vehicles that we can use to help not only educate
the producer, but all of us that do consume.
And before I end my points, I do want to
remind you -- and I think it has been said
before -- that there's probably -- there is more
130
risk to your health of not consuming fresh fruits
and produce and vegetables than there is of
consuming some that are contaminated.
So keep on eating your veggies and your
fruits, fresh veggies and fruits, do that. It's
healthy. Very healthy.
Thank you.
MS. ISAACS: Are there any questions for
Dr. Gomez?
MS. TRUNK: I'm Maria Trunk (phonetic) from
the Tropical Fruit Island, a grower, shipper,
packer in Homestead. We are also importers of
tropical fruits and vegetables from the Carribean
and Central and South America.
I have two questions. Just drawing on my
experience in working with plant quarantine
issues, I've seen that a pattern of APHIS and ARS
working very closely together to quantify pest
risks from produce from other countries and then
developing treatments or practices which
adequately address those risks.
Is this the kind of research that you would
envision, this kind of risk assessment would be
done in this -- in this case?
DR. GOMEZ: I really don't know at this
131
point. I think there must be a risk assessment
type avenue in there, yeah.
DR. TROXELL: Let me just comment that --
and, obviously, this initiative is focusing
totally on microbes, not other aspects.
Microbiological quantitative risk assessment
is pretty much in its infancy. There are very
few quantitative risk assessments actually
ongoing, and one that I'm aware of is for -- for
eggs from farm to table that the USDA is doing.
This is a developing field, and it will be
applied as it develops. There are qualitative
risk assessments that are done all the time and
that have been done for years in food programs.
So we do not -- do not really have the
complete tools to be able to do quantitative risk
assessments at this time for microbiology
problems.
MS. ISAACS: Can you all hear in the back?
Perhaps you weren't close enough.
MS. TRUNK: Okay. I'll ask my second
question, then.
I guess I'm just a little bit unclear on how
this all fits together, but we saw at the
beginning of the presentation a time table that
132
called for a final guide to be issued in the
summer of '98, and yet we're hearing that maybe
research funds won't be available until fiscal
'99. How does this all fit together?
DR. TROXELL: This does not anticipate
complete answers on all the science. That's why
the document will be using a lot of relative
terms; it's better to compost longer than shorter
and, you know, not specific times and so on.
We need a lot of research to be able to
pinpoint all the answers. Once those answers are
pinpointed, then there could be much more, you
know, very, very concrete advice.
But at this point, the information isn't
available, and as it becomes available, guidance
will be revised and practices -- recommended
practices will be changed.
DR. GOMEZ: I want to tell you a little
story to Brooks here.
I was involved in the ethylene dibromide
problem when mangoes from Santo Domingo or Haiti
were starting to be brought in, and there was a
tremendous panic.
But through working with ARS, with the
Experiment Station System also, and with APHIS
133
hand in hand as partners, that problem was
resolved.
So there are opportunities for this in the
future and I hope they will be resolved, as well,
working as partners. Not one agency can do it
all by itself, but working together, we can solve
some of these problems.
MS. ISAACS: Anyone else?
DR. BEASLEY: In two of the documents you
passed out this morning --
MS. ISAACS: Could we have your name,
please?
DR. BEASLEY: I'm sorry. Larry Beasely with
A. Duda & Sons again. And I'll try not to be as
emotional as I was earlier in the day. I get
frustrated from time to time.
It says in here that 9,000 deaths are
directly linked to food-borne pathogens and
that's in two different places in that handout.
Not the one that you prepared, but handouts we
were given outside here.
How many of those 9,000 deaths are due to
pathogens found on fresh fruit and vegetables?
Anybody?
DR. TROXELL: I don't think we have an
134
answer to that.
DR. BEASLEY: Then we don't know what the
risk is, do we?
DR. TROXELL: Well, the percentage of the
outbreaks associated -- and cases of illness
associated with produce has gone up. It had been
fairly minimal. It's now up to, I believe, five-
eighths to eight percent of the total outbreaks
and illnesses.
The known cases are generally considered the
tip of the iceberg because the monitoring systems
do not allow you to really understand the full
magnitude. And there have been estimates that,
based on what's -- what your known illnesses are,
the actual illnesses are 50 to a hundred times
larger.
DR. BEASLEY: Well, you state in here, six
and a half to 33 million illnesses. And I'm only
directing this to deaths.
And what I'm asking -- my question is: How
many of those deaths are related to fresh fruit
and vegetable; not eggs, not meat, not something
cross-contaminated by meat; something that you
directly trace back to fresh fruit and
vegetables?
135
MR. BARNES: I --
DR. BEASLEY: Not the processed vegetables,
but --
MR. BARNES: And I don't know that -- I
don't have any of that data here. I don't know
if that data's available, because normally it's
traced back to an organism. And I'm just looking
at the list of Salmonella, E. Coli 0157, Listeria
monocytogenes, which all have been found in fresh
fruits and vegetables, which can be very serious,
even life threatening to high risk possible
populations, regardless of the vehicle.
And those numbers are -- where the deaths
come from are the numbers people have died from
specific organisms, not necessarily from a
specific outbreak that -- I mean, I don't have
that data here. It may be somewhere.
The Center for Disease Control and
Prevention may have -- maybe it will link it
directly from the organism back to the product
and be able to tell you that, but I don't have
that data.
DR. BEASLEY: Could someone from this august
group get some information like that back to us
to so that we know what the risk is?
136
MR. VANDERVEEN: What we can give you is the
work of the subcommittee -- produce subcommittee
of the advisory committee on microbiological
quality of food in which they have listed from
the literature those cases associated with
produce outbreaks, and we will -- we will provide
you that.
DR. BEASLEY: Thank you, sir.
MS. ISAACS: Okay. Moving right along.
We are into the industry group presentations
ahead of time. Thank you everyone.
And at this time, I would really like to
thank Dr. Stacey Zawel, she's the Director of
Scientific and Regulatory Affairs with United
Fruit & Vegetable Association based out of
Alexandria. And she and Michael Stuart with the
Florida Fruit and Vegetable Association in
Orlando, were able to arrange some member
speakers to start off the industry segment.
So we really -- and the tremendous job they
did in publicizing this event in a very short
turn-around and getting the draft out to their
members. We appreciate it so much.
So Stacey, did you want to say a few words?
DR. ZAWEL: Thanks, Lynn. I just want to
137
say very few words, actually.
What United has done in this process is
tried to take advantage of these meetings and
capitalize on them, Michigan, New York as well as
the rest of them all along the road, to put
together a number of industry experts to convey
and to represent numerous commodities, why
certain practices are followed, to demonstrate
the diversity and complexity of the industry, as
well as conveying what's practical and reasonable
for the industry to do, and demonstrate that, in
fact, the industry takes the issue of food safety
extremely seriously.
In Florida, we have, in all cases, rely
very, very heavily on the local associations,
regional associations to identify the appropriate
people and, therefore, I want to thank Mike
Stuart, the President of the Florida Fruit &
Vegetable Association, and the rest of the
association in the effort that they have put
forward to identify the appropriate people in
Florida.
With that, Mike.
MS. ISAACS: Mike, would you mind coming --
I think it works out a lot better if you're not
138
shy and don't mind coming up to the front podium.
It makes it a lot easier as far as transcription,
and easier for all of us to see you and hear you.
MR. STUART: Thank you, Lynn. And I too
want to thank Dr. Zawel for all of her efforts in
coordinating the industry's examination and
responsive participation in this whole effort.
This is, as I think we've all discussed here
today, with the complexity of this industry, it's
very difficult to bring an industry together from
various sections of the country and throughout
North America, for that matter, what they've been
involved with here, try and play a good, strong,
constructive role in this process.
Again, my name is Mike Stuart. I'm the
president of Florida Fruit & Vegetable
Association, and we're an organization represents
vegetable, citrus, tropical fruit and producers
of other agricultural products in the state.
As has been mentioned here -- I know
Dr. Roberts mentioned it this morning and others
have as well -- we have a very diverse and
complex industry here in the state. The fruit
and vegetable sector represents about 50 percent
of the entire industry. It's about $3 billion
139
worth of farm gate value on an annual basis. We
lead the nation, I believe, in some 14 different
fruit and vegetable crops including citrus,
tomatoes, green peppers and others.
I think, again -- and I hate to reiterate
something that's been mentioned by people
earlier, but eating a diet rich in fruits and
vegetables is extremely important to the health
of all Americans.
And along those lines, for several years,
FFVA along with a partnership of literally
hundreds of different organizations and companies
around the country, has been actively involved in
promoting that message of eating five servings of
fruits and vegetables a day in partnership with
federal agencies like the National Cancer
Institute.
I am happy to say that we are making, I
think, some excellent progress in that goal.
When we started out in 1989, 1990, consumption
was at about three to three and a half servings
per day. We're looking for some data to come
out, hopefully, earlier next year that will show
us somewhere between four and four and a half
servings of fruits and vegetables a day for the
140
American population.
So we are making some progress. And I think
it's important, as we move through this process,
to ensure that we're doing something that will
encourage people to eat more fruits and
vegetables and not frighten them away from eating
those very important products.
We do believe that our industry, and in our
membership in particular, produces a very safe
and wholesome product throughout Florida. We
comply with literally a myriad of state, federal,
and local regulations, many of which have to do
with providing a sanitary and healthful product
to consumers. But along those lines, we do
obviously support science-based efforts to
further enhance the wholesomeness of fruits and
vegetables consumed here in Florida throughout
the United States.
As an industry, we recognize that the
incidence of food-borne illness attributed to
fresh produce has increased over the past ten
years. Unfortunately, other than the
epidemiological studies that have been conducted
with each reported illness that we've had during
that time, there's really been insufficient
141
research conducted to determine the source and
cause of many of these outbreaks.
We have, however, particularly over the last
few years, I think, approached this whole issue
in a very proactive manner. Last year, we began
a process within our own organization to assist
our members in the identification and mitigation
of potential sources of microbial contamination
of fruits and vegetables.
Our growers' check list for microbial safety
on such produce was developed and designed under
the simple premise that consumers deserve the
ability to purchase produce that has been
produced, distributed, and marketed in a manner
which minimizes the risk of food-borne illness.
Another key premise of the document,
however, was the fact that crops such as fresh
fruits and vegetables which are produced in a
natural environment cannot be expected to be
completely free of microbial agents.
Here just recently, the National Advisory
Committee on microbial criteria for foods, which
was just mentioned here just a minute ago,
reinforced that reality in a white paper that was
produced here, I believe, the week before last,
142
which stated, and I quote: "The focus of
activities must be realistically directed towards
risk reduction and not elimination."
I need to also point out several other
industry initiatives have also been undertaken in
the whole area of microbial safety. FFVA worked
closely with Dr. Zawel and the United Fresh Fruit
& Vegetable Association as well as 18 other fruit
and vegetable -- primarily producer organizations
from around the United States and throughout
North America, for that matter, in the
development of industry-wide guidance to minimize
microbiological food safety risks for produce,
which also focuses on risk identification and
mitigation at the grower, shipper, handler level.
Additional efforts have also taken place on
the West Coast with Western Growers Association
in cooperation with the International Fresh & Cut
Produce Association. I know the Florida
Department of Citrus and several other
organizations around the country have also taken
a proactive effort in addressing these issues and
providing industry guidance back to the industry.
I think it's important, though, to point out
that in each of these cases, these efforts have
143
taken several months, if not years, to develop
among people who are intimately knowledgeable and
versed in the application and production of
different cultural practices within the industry.
We also have worked closely with the Fresh
Produce Subcommittee of the National Advisory
Committee to identify these risks as well. We,
along with United Fresh Fruit & Vegetable, hosted
the Fresh Produce Subcommittee down here in
Florida a year ago -- actually, it will be two
years this coming January, to go out literally
and spend some time in the fields and the groves
and the packing houses so they could get a
firsthand view of what's going on here in Florida
so that they have a good, sound basis for making
the recommendations.
Unfortunately, we still have many unanswered
questions regarding the introduction and
transmission of food-borne pathogens and fresh
produce and that was an assessment that was drawn
by the subcommittee, and we strongly agree with
that assessment.
We appreciate that the agents' draft
guidance to minimize microbial food safety
hazards for fresh fruits and vegetables has been
144
developed as guidance as opposed to regulation;
we think that is obviously very positive for the
industry. But as has also been mentioned here,
and I need to reiterate that, you need to
recognize that, although the federal government
has taken great pains, I believe, to try and
ensure all of us that this is, in fact, guidance,
I think its application in the marketplace needs
to be closely examined. And although you do
consider it guidance, I think, as we move down
the road here, the buying end of our industry may
dictate otherwise.
The draft document has also been put
together in the two months since the announcement
of the President's Initiative, and we are very
concerned, quite frankly, with the speed in which
this train is moving down the track.
Again, the produce industry is highly
complex and diverse and what may be applicable to
one commodity may not be applicable to another,
or what may be applicable to one producing area
certainly may not be applicable to another. That
is accurate, I think, here in Florida as well as
throughout the country.
It is essential that the complex and diverse
145
nature of our industry be taken into account.
And this -- we've heard, I think, this time and
time again today, and I think you'll hear it more
as other industry people get up to speak. We
seriously doubt that this agency can really
accurately put together this kind of document in
the type of short time period that you've
described here today.
Any guidance also must have a strong
scientific basis. It's clearly been identified
by the Fresh Produce Subcommittee that more
research needs to be conducted on how, when, and
where this contamination occurs. It needs to be
addressed, though, not just at the production
level, but throughout the distribution chain all
the way to the table.
Contamination can occur anywhere in the
chain, and it's been well documented in recent
years, particularly by public health officials,
that much of the contamination occurs at food
preparation sites, whether in food preparation at
restaurants or particularly in the home.
While it's been shown to be incidents of
food-borne illnesses associated with fresh
produce have increased in recent years, it's
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important, however, to put the relatively few
incidents involving fruits and vegetables into
context with the one billion servings of fruits
and vegetables that are consumed by Americans
every single day. It should also be pointed out
that not only has consumption of produce
increased during that time, but more importantly,
the amount of fruits and vegetables imported in
the United States has risen dramatically during
that time as well.
According to federal statistics, the amount
of imported fruits and vegetables consumed in the
United States has basically doubled in the past
ten years. Meanwhile, it's also been reported
that FDA testing of imports has declined.
Although the initial thrust of the
President's Initiative seems to be focused on
imported foods, the domestic industry now seems
to be the focus of this initiative and this
guidance effort. It's important the focus of
this effort be directed on those countries where
the sources of these food-borne illnesses are
commonly found or endemic.
We also believe that a key element in the
President's Initiative should be to provide
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consumers with information on the country of
origin of the produce they buy at the
supermarket. If you visit any Florida store,
grocery store, you would find country of origin
labeling in each of the bins where those products
are located. Florida and Maine, to date, are the
only states in this country that require country
of origin labeling. Consumers have told us time
and time again in research studies that they want
that information. We agree that they should have
it.
We encourage and we urge the FDA and the
USDA to move forward cautiously and slowly with
this initiative, taking into account the
implications not only on the production of fruits
and vegetables, but what implication it might
have on the marketplace itself. Any guidance
should be based solely on documented risk and
science-based solutions. There is no need to
move at the current rapid pace.
Those involved in the development of the
document need to fully understand current
industry practices, as well as the myriad of
state laws and regulations that impact this
industry. This means more structured industry
148
input as well as getting all of you out into the
field, out into the groves and packing houses to
see firsthand how our industry operates.
Again, we appreciate the opportunity to
appear before you today. We thank you very much
for providing all of us the opportunity to
participate in this particular session. We do
urge you to get the industry more involved on a
daily basis with this effort.
We have a number of industry people here
that will speak either representing a different
grower organization or individual representatives
themselves over the next hour or so. So we look
forward to hearing their input.
And, again, I thank you very much from all
of us.
MS. ISAACS: Thank you, Mike.
I might add, Mike, that a couple of us
dietitians here today -- Judy, do you want to
raise your hand -- serve as very active members
of the Florida-based partnerships and we do have
most of our meetings at your office, of course.
Okay. Next, we'll have Mr. Bobby McKown.
Did I get your name right?
MR. McKOWN: That's correct.
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MS. ISAACS: He's with Florida Citrus Mutual
out of Lakeland, Florida.
MR. McKOWN: Good afternoon, and welcome to
each of you and thank you for the agencies and
the representatives here today coming down to
allow the opportunity for the various interests
in Florida to give their viewpoint relative to
the issue at hand.
My name is Bobby F. McKown, I'm executive
vice president and CEO of Florida Citrus Mutual.
Florida Citrus Mutual is a voluntary cooperative
association whose active membership consists of
11,676 citrus growers operating within the State
of Florida.
The comments we're offering you today, we
offer those, we believe that they are factual and
we bring some points to you that we think you
should give serious consideration as you do the
further deliberation relative to the proposal at
hand.
Florida Citrus Mutual generally supports
existing federal and state initiatives geared
toward increasing assurances of fruits and
vegetables whether produced domestically or
imported are safe. Florida Citrus Mutual has a
150
long history of working very closely with the
Food and Drug Administration, the U.S. Department
of Agriculture, IFAS, the Florida Department of
Agriculture, the Florida Department of
Environmental Protection, the United States
Department of Environmental Protection, all to
make sure that we have the world's safest and
most abundant supply of affordable foods and
particular with citrus and processed citrus
products.
Citrus Mutual endorses the comments of
Florida Citrus Packers, which you will hear
today, the Florida Department of Citrus, the
Florida Department of Agricultural Consumer
Services, and the Florida Institute of Food and
Agricultural Sciences.
Fresh Florida citrus is highly regarded
throughout the world as a safe and reliable
source of nutrition and plays a vital role in the
health and the well-being of many of the less
privileged countries and nations throughout this
world.
Florida citrus growers are rightfully proud
of their heritage, of global food and safety
records. And that is a strong testimony for
151
their diligent efforts to continue in that
tradition. Never in the history of the Florida
citrus industry -- and I repeat again -- never in
the history of the Florida citrus industry, has
there been a case of food-borne illness as a
result of the consumption of fresh Florida
citrus.
And as an aside, we spend -- the growers
are assessed in excess of $12 million a year in
order to provide continuous inspection at the
receiving points, at the processing plants, at
the packing houses, and all the way through the
finished product that is shipped then to the
consumers of these United States and throughout
the world. $12 million of continuous USDA
inspection. And I say to you that we have that
total safety net in place and we support that
proposition.
Nevertheless, Florida Citrus Mutual strongly
supports continuous inspection for all fresh and
processed citrus, domestic, as well as imported.
Frankly, that's not the case relative to imported
products coming into this country whether it be
processed or fresh.
Florida Citrus Mutual further believes that
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vigilance is the key to maintaining the best
reputation for safety among our global trading
partners and stands ready to cooperate with state
and federal efforts to ensure global food safety
for all nations.
And we strongly urge that any guidance
recommendations be based solely upon the most
sound science. And if you do not have the
science, that you don't rush to judgment to make
that decision prior to having that science when
there's no proven problem and the best available
information about the growing, the harvesting,
the handling, the processing, and packaging of
any fruits and vegetables foreign or domestic.
In this regard, while many of the
recommendations provided in the current guidance
document are well-recognized industry practices,
certain others are rather inappropriate for the
following reasons:
Number one, as stated earlier, the naturally
protective peeling on fresh citrus, coupled with
current well-recognized industry practices aimed
at sanitary growing, handling, and packaging have
established the highest degree of food safety and
set the standards in the world marketplace.
153
Two, in the production stages of citrus,
there is very little likelihood of contamination
from irrigation water because the industry
standards of low volume under-tree microjet
systems direct their spray away from the fruit
and toward the surface of the root zone. These
systems routinely require ozonation or
chlorination to prevent clogging.
Furthermore, irrigation is only done on an
as-needed basis, carefully monitored by state and
local agencies, and growers are required to
identify their sources of irrigation water and
carefully monitor both quantity and quality of
withdrawals as well as discharges. Any existing
very small overhead irrigation is rapidly being
phased out of our industry, in fact, it is almost
non-existent today.
Any irrigation utilizing reclaimed water is
carefully monitored for quality control by
suppliers and must meet stringent state and
federal guidelines. Further periodic testing of
water sources for microbial contamination in the
field is unwarranted, time consuming, and
expensive.
Florida citrus growers in certain areas of
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the state rely heavily on surface water from
reservoirs, rivers, and stormwater retention
basins for their irrigation needs, and these
sources have been carefully monitored by the
state water management districts, under the
careful and watchful eye of the Department of
Environmental Protection to ensure the continued
safe use of these sources. These state agencies
have carefully undertaken massive efforts to
significantly enhance water quality in every
single one of these systems.
The guidance documents suggest consideration
be given to total protection for open water
bodies. But this is impractical and unwarranted,
in our opinion. Florida has established a
classification system for surface and subsurface
water bodies and a vast, oftentimes redundant,
network of regulations serving to protect and
enhance water quality.
This has served as a model for many other
states throughout these United States. And, in
fact, Florida was the lead state that moved in
the development of water standards at which we
operate today.
Whereas the guidance documents suggest
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consideration be given in the decisions being
made with regard to adjacent land use
compatibility, the recommendation has merit where
feasible. Florida's rapid population growth has
taxed existing conditions that safe potable water
and pressure has come to bear on growers in some
areas to accept the lowest quality of water
available for irrigation purposes.
Florida Citrus Mutual has played a key role
in the development of rules and regulations to
protect the integrity of the excellent reputation
of the industry by requiring careful monitoring
of treatment and delivery processes of reclaimed
water whenever state agencies has encouraged or
required its use.
In addition, we played a key role in the
development of state and federal guidelines for
sludge application for citrus and in the
application of groves throughout the State of
Florida where used.
Although the practice is very limited, we
believe that key safety measures have been
adopted to control application quantity and
quality. We further believe that efforts within
the citrus industry to regulate worker activities
156
in the grove aimed at safeguarding against
pathogenic contamination of citrus would be
unwarranted and misdirected. Worker activities
in the grove are not entirely controllable and
workers are sensitive to their privacy rights.
And I can assure you that that is a very key
element that is a management decision in working
with employees today; you, too, must be very
cognitive of their privacy rights.
Education is the best method to address the
possibility of any contamination of packed and
processed fruits and vegetables. Efforts in this
respect are strongly supported by the state trade
associations, IFAS, universities, the Department
of Citrus, Florida Department of Agriculture,
USDA and others.
In conclusion, I would say to the panel and
those in the audience today, Florida Citrus
Mutual firmly believes a threat of contamination
of microbial hazard should be addressed for
continued rigorous inspection efforts of all
fresh and processed citrus at packing and
processing plants and at port of entry.
As a practical matter, so much has been done
up to this point to ensure food safety and
157
production agriculture that the most likely
causes of contamination would be in open air
marketplaces, improperly protected displays at
retail locations, and failure on the part of
consumers to exercise best judgment in the
handling, storage, and preparation of the
produce.
All the best efforts of the growers must be
complemented by the best efforts of wholesalers,
retailers, consumers, and Florida Citrus Mutual
applauds the effort of federal and state agencies
to ensure that growers' efforts are not in vain.
Because, frankly, we are doing those things
today to make sure that the product we delivered
wholesale into the distribution channel trade
within this country and other countries, that we
meet the very high standards. Because the basic
premise of advertising and promoting Florida
citrus of which the growers assess themselves
approximately $80 billion a year to promote our
product, is the one hundred percent purity of our
product.
And I can assure you that we have a greater
desire to find and know the problem long before
an agency of the government's going to tell us,
158
because that's the number one item that we
protect, and that's the purity of our product and
the wholesomeness it represents in the
marketplace.
So in closing, Florida Citrus Mutual
supports continuous inspection of all fresh and
processed citrus, foreign and domestic, as well
as all efforts aimed at the most likely sources
of contamination as identified by sound
scientific evidence, and the most sufficient
means of controlling, including increased
consumer awareness and education is our belief
that that's what the major goal must be of any
actions undertaken.
So I thank you for allowing me the
opportunity to express these comments on behalf
of Florida Citrus Mutual and its almost 12,000
members, and we continue look forward to continue
to work with you.
Thank you.
MS. ISAACS: Thank you, Mr. McKown.
Now we're going to hear from Dr. Chip
Hinton. He's with the Florida Strawberry Growers
Association in Plant City, Florida. And we
always try to do food demos in cooperation with
159
Extension Service at the Strawberry Festival.
Wonder why.
DR. HINTON: When we put this program
together, I'm sure it was more than coincidental
that in order to demonstrate the diversity of our
commodities, that we had citrus, which is our
largest fruit, followed by strawberries, which
has half the acres that they have members.
I appreciate this opportunity to address the
issue of microbial safety of our produce. I also
want to assure you that every agriculturist in
this room supports your objective and is open to
your suggestions on how we can do an even better
job of assuring food safety for our consuming
public.
You must believe that our comments relative
to process are not meant to be obstructionist,
but are aimed at reaching our mutual objective as
painlessly as possible.
Let me tell you a little about Florida
Strawberries. As mentioned, we are located in
the Plant City, Dover area. We have the
interesting dichotomy of being a small family
operation; our median size farm is 19 acres, our
average size farm is 34 acres. Total plastic
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culture, one hundred percent drip irrigation.
At the same time, we're a $120 million
industry and we employ over 9,000 workers, field
level. There's some advantages in having
virtually 20 percent of the production of
strawberries in a nation within a 20-mile radius.
One of them is that we are not only a small
family, but we're a large community. And we work
together and we can, in fact, get the entire
community together under one roof in our
educational process.
I want you to know that the Florida
strawberry industry has tried to be ahead of the
curve on food safety. Every year, we hold a two-
day educational session; we've done this now for
15 years, to address topics like field
sanitation, in fact, that was the topic of our
discussion this past summer, and that over
80 percent of our growers attended that
particular session.
Food safety is a regular item on our grower
newsletters, both through our Florida Strawberry
Growers Association and through our sister
organization, FFVA, and our entire membership is
enrolled in FFVA. We cooperated with voluntary
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industry-wide efforts to develop GMPs for field
level protection of produce, as Mike mentioned.
And we have an outstanding relationship and
a mutual respect for both the Institute of Food
and Agricultural Sciences, which co-sponsors our
two-day session, and the Florida Department of
Agricultural Services. We view them both as
willing cooperators and outstanding resources to
solve problems.
Within our system and our design, we
recognize that with 9,000 workers, that's
probably the most limiting practice that we have.
Our production occurs within 20 miles of our --
of a pre-cooler; harvests are immediately cooled
and they are, in fact, kept refrigerated, 34
degrees, as long as they are within our control.
Our workers -- and I've been on virtually
every farm that we have -- have a situation field
sanitation that is regulated at the state level
both in number of facilities and distance to
facilities with potable water, hand-washing
facilities and so forth. We have incorporated,
through our WPS program, an addition of field
sanitary systems this past year, and so we are
really doing everything we can short of holding
162
people's hands to assure the necessity of good
field sanitation.
I think one of the things that you may not
have been totally aware of until today was that
agriculture is already pretty well regulated.
The perception is there's very little regulation
of agriculture at the field level.
An extension agent in Hillsboro County once
took a project of identifying agencies regulating
agriculture and he provided a brief synopsis of
the rules and permits required for each agency.
The guide quickly grew to 1,080 pages.
We developed a case study with use in
farming for the future to determine the impact of
regulations on agriculture, and we sent out a
questionnaire to those regulatory agencies that
would have impact upon an agricultural facility.
We contacted 46 regulatory agencies. Forty-six
agencies. Many with multiple permits, several
duplication services with other agencies, and
most not realizing how each related to the other
agencies.
Some of your guidance bullets address
sources of irrigation water. In West Central
Florida, virtually all of our production is
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within a water use caution area. Both quantity
and source are regulated and metered. Switching
and moving permits is closely monitored and
extremely difficult. As I mentioned, we're
virtually a hundred percent drip irrigation. So
most of our production water is used -- is ground
water.
One of the things I'd like for you to
understand in your development of your
regulations is, when you develop BMPs, so many of
them interrelate and overlay. I'm going to give
you a little anecdote, a true anecdote, that has
occurred to us over the past several years.
As I mentioned, we're a hundred percent drip
irrigation. There were a number of reasons why
we made that conversion. First of all, we
determined that we could save roughly 40 percent
of our water, and we were under some pressure to
reduce water usage in our production of
strawberries.
One of the things we quickly discovered was
that we would also be able to fertigate through
the system which, in fact, reduced our fertilizer
use by roughly 45 percent by putting the
fertilizer right at the root zone. That made not
164
only the water quantity, but the water quality
people happy.
When you're putting water at the root zone,
you don't get the plant wet, which reduced our
incidence of disease. As we mentioned, water is
the carrier. That reduced our pesticide use by
15 to 20 percent.
Now, when we had an increased harvest as a
result of that -- we increased our harvest by
25 percent as a result of that, and our
marketable fruit, which made everything much more
productive.
So here we are, we've reduced water use by
roughly 40 percent, fertility requirements 35 to
40 percent, protected our water quality, reduced
disease, increased marketable fruit by
20 percent, and reducing our pesticide use by 15
to 20 percent.
Then in 1994, the month of February, we
didn't get a drop of rain. And Canada, which has
an MRL of 20 percent of that of the U.S. on
Captan, started rejecting our strawberries. The
problem was that with our dry plants and without
overhead irrigation, we didn't have anything to
rinse off the Captan in the process.
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Now we solved the immediate problem by
cranking up our overhead irrigation, which
removed about eight or nine percent of the
residues, and we followed up with grower
education programs and we haven't had a problem
since.
I mention that because that's the one
incidence that we've had with FDA, and our one
black eye of involvement in 1994. And I'm
bearing my soul just so that you understand that,
number one, that when you have a best management
practice, it's a moving target, and while we
consider it to be moving in one direction, it
moves both ways.
When we use overhead irrigation to
accomplish what I consider a trade issue more
than a food safety issue, we will have to have
more water than what we would need under drip
irrigation. This will affect our fertility, it
will affect disease and everything else. So when
you make a regulation, when you make a
recommendation, you need to understand that there
may be unanticipated results.
As an addendum to that anecdote, I would
like to say that Martha put on another hat and
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she told us that in order to maintain her
credibility -- and we encourage her to do so --
that we would be under a lot of scrutiny the
following year. Every one of our growers was
inspected the following year. We had zero
violations.
I think that that probably is a testimony to
the fact that we try to do what is best for our
community. BMPs are not isolated; they're
convoluted, interrelated, and complex. They may
be influenced by other BMPs and missions, and
sometimes diverse direction occurs when they are
compromised by other competing missions.
You need to know all the players, the other
missions, and to minimize any anticipated
negative results, you need to think ahead. It's
desirable to identify impacts before they become
recommendations which may become regulations.
You say that you're talking about
recommendations and guidance, and I believe you.
I think in my 25 years of similar jobs such as
I'm working right now, I have found one thing to
be true, and that is that once your
recommendations are made, it's really out of your
hands. You don't have control if they become
167
regulations by de facto or by outside influence.
So if you cannot resolve the problem after
it leaves your hands, your emphasis must be
before it leaves your hands. And you can
accomplish a whole lot, first of all, by making
sure that what you have is based on science,
based on practical information and, for God's
sake, not on giving us something to shoot for.
I wish I had a nickel for every time a
regulator said, this will not be binding, but we
want to give you something five years down the
road to shoot for. Because no one can tell your
business better than you, and no one can tell
whether that target is a realistic target.
You need to be aware of the tremendous
diversity in production practices among the
numerous commodities you are addressing. It may
be reasonable for my industry to trace back
produce beyond the shipper, beyond the grower, to
the individual worker in the field. And we can
do that; we can actually tell you what worker
picked a flat of berries. I say that because a
lot of our people are doing it because we want to
maintain our own quality control.
But, secondly, you need to understand that
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most of our berries are broken up somewhere
before they get to the consumer, and we have no
control over that. The train of information is
lost at that period.
There was some discussion here relative to
collateral damage. The incidents that we have
had recently relative to strawberries, incidents
of cyclospora and E. Coli both occurred when we
were not in production. That's probably the only
safe way to say that you can be assured that
things could not be traced back to you; we were
not producing at that time.
And I can't speak for my friends in
California, but I know them well, and I have been
assured from some very reasonable sources that
they were not the source of that problem as well.
We lost some money as a result of that
situation, even though we weren't in production,
because people thought of strawberries in a
different way than they had prior to that
information. I know for a fact that California
lost over $40 million on the second incident
alone, and they were not at fault.
We have the same ultimate objective and that
is public health. Please move slowly and
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carefully and minimize the negative impacts on
growers.
A diet that is a cornucopia of fruits and
vegetables is in the best interest of the
consumer. It's important that one of your
unanticipated impacts not be the reduction of our
domestic supply of fruits and vegetables.
A reduction of supply of produce will
influence the cost to the consumer, a reduction
in domestic supply of produce will influence
public health.
Thank you.
MS. ISAACS: Thank you, Dr. Hinton. Next
we'll hear from Dr. Mohammed Ismail. I hope I'm
not fracturing your name. Was I close?
DR. ISMAIL: Very good.
MS. ISAACS: What's the proper -- tell me
what your pronunciation is.
DR. ISMAIL: It's pronounced in many
different ways.
MS. ISAACS: All right. I'll say Ismail
then. Okay?
DR. ISMAIL: Ismail.
MS. ISAACS: Ismail. Dr. Ismail is with the
Florida Department of Citrus out of Lake Alfred,
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Florida.
DR. ISMAIL: Thank you, Madam Chairman,
distinguished members of the head table, ladies
and gentlemen in the audience.
It is true, my name is Mohamed Ismail. I
work for the Florida Department of Citrus and
serve as the Scientific Research Director for
fresh fruit.
Our staff is located at the Citrus Research
& Education Center at the University of Florida,
Lake Alfred. The Scientific Research Department
was established in 1941 and, believe it or not,
by an act of the Florida legislature, and we were
moved to Lake Alfred about 50 years ago.
I have a Ph.D. in horticulture and I
specialize in post-harvest citrus technology,
including packing house operations and quarantine
treatments.
The department staff includes engineers, a
plant pathologist, plant physiologists, chemists,
and food scientists and microbiologists. The
Florida Citrus Commission and the Florida
Department of Citrus, as a unit, is a government
agency established in 1935 by an act of the
Florida legislature as a result of an industry
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request.
The act called the Florida Citrus Code
states -- and it is ironic in a way that how the
words are put together -- that the commission,
department was set up to protect and enhance the
quality and reputation of Florida citrus fruit
and processed citrus products in both domestic
and foreign markets.
It also acts to protect the health and
welfare and stabilize and protect the citrus
industry of the state which, in turn, helps
promote the general welfare and social and
political economy of the state.
The Florida Citrus Commission, Department of
Citrus is financed by an excise tax placed on
each box of citrus moved through commercial
channels. The Florida Citrus Code stipulates the
maximum tax and how funds generated are
allocated. The portion of that tax is deposited
in the state's general revenue fund to offset
administrative costs.
We do support local, state, and federal
efforts to enhance food safety and improve the
quality of our food supply. We also believe in
the importance of a healthy diet, rich in fresh
172
fruits and vegetables as part of a healthy
lifestyle, and citrus does figure prominently in
the diet as a good source of many vitamins and
minerals.
The edible portion of the fruit, of the
citrus fruit, is naturally protected by the peel
against microbial contaminants, and it is also
further protected by a natural abundance of
citric acid and other organic acids creating a
low pH environment, ranging between 3.2 in
grapefruit, to 4.0 in oranges, which can deter a
large number of disease causing organisms.
Nevertheless, we support the implementation
of sanitary measures and guidelines which would
strengthen and enhance the safety of fresh citrus
and fresh citrus juice.
As a state agency, the Florida Department of
Citrus has placed a great deal of emphasis on
education through publication of fact sheets,
passive manuals and workshops. We have just
released two fact sheets on the microorganisms on
food and beverage and on reducing the risk of
microbial contamination of fresh citrus fruit.
We also collaborated on preparation of a
model of Hazard Analysis Critical Control Point
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for the fresh squeezed juice industry. And in
1996 and 1997, we organized workshops on
microbiologic safety of fresh-squeezed citrus
juices.
So we definitely place a great deal on the
education side informing our constituents of the
best science and the best research results and on
the importance of education.
We also have a very active research program
as we are the scientific research department of
the Florida Department of Citrus. We conduct
research on fresh fruit, on fresh-cut, and fresh-
squeezed citrus juice. Our research activities
include challenge studies on peeled, fresh-cut
oranges using Salmonella, E. Coli,
staphylococcus, and Listeria.
We are also studying microbial contamination
of fresh citrus fruit and are developing physical
and chemical methods for surface disinfection.
Our research staff will continue to survey the
microflora of citrus fruit in the grove, the
packing house, and in fresh-squeezed juice
plants. We plan to also conduct challenge
studies and develop effective preventative
measures and food surface disinfection methods at
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various points of production and packing and
distribution.
It is very important to recognize the
potential for contamination of fresh fruit and
vegetables that can occur in retail and wholesale
outlets, and, indeed, in the hands of the
consumer. These are areas of utmost importance
which needs to be studied in order to develop
sound and objective protective sanitary measures
and practices. And these are areas that I do not
see in the guidance document; what happens at
retail, wholesale, and in the hands of the
consumer.
Florida produces approximately 250 million
boxes, which is approximately 10.2 million metric
tons, of oranges, and about 55 million boxes of
grapefruit, which is approximately 2.2 million
metric tons. While only six percent of our
oranges are shipped fresh, most of the
tangerines, tangelos, and grapefruit are shipped
fresh. When recommending guidelines, we must not
lose sight of the intended use of a given crop.
An orange crop harvested for processing, which
includes a potential kill step, can be handled in
a manner different from oranges or other citrus
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fruit picked for the fresh fruit market.
The Florida fresh citrus packing industry
benefits not only from the natural protection of
a divinely designed fruit, a citrus fruit, but
also from certain common practices in our groves
and citrus packing house operations.
Among these -- and I might be a little bit
repetitious here -- the extensive use of under-
tree irrigation, the microjet systems which
minimizes exposure of fruit to irrigation water,
fruit trenching at the packing house with
chlorinated and ozonated water with automated
control of pH and chlorine concentrations, the
use of automated systems to clean and sanitize
harvesting bins, also the increased use of
plastic bins that minimize fruit damage and aid
with bin cleanliness. The use of sanitizers such
as chlorine and quaternary ammonium, compounds to
clean degreening and storage room and packing
line equipment. The increased use of high
pressure washers to improve fruit cleanliness and
the use of automated grading and packing systems
to minimize human contact. And, finally, the
increased use of refrigerated storage and
refrigerated transport.
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Finally, I would like to mention that each
commodity is unique in the way it is grown,
handled, shipped, and ultimately consumed. To
recommend implementation of one set of
regulations to all fruits and vegetables, in our
opinion, is inappropriate.
Thank you.
MS. ISAACS: Thank you, Dr. Ismail. And now
we will hear from Dr. Larry Beasely, who I think
we've already heard from earlier today, but maybe
a little more extensively.
Dr. Beasley is with A. Duda & Sons,
Incorporated back in the Central Florida area
from Oviedo, Florida.
DR. BEASLEY: Central Florida, South
Florida, Texas, Arizona, and California. And I
get to visit all of those. I haven't been home
in two weeks, and I will get home next week,
along about Wednesday.
There's one thing I'd like to thank all of
you for, and that means you in the group here, as
well as the medical association and the
universities. During my lifetime, my life
expectancy has increased by several years, and I
found out this morning that it's due in part to
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the consumption of fresh fruit and vegetables.
plan on continuing to eat them.
In addition to that, I'd like to also point
out to you -- and I think the point's already
been made, but I'd like to reiterate -- that
first and foremost, as a producer of fresh fruit
and vegetables, we have a responsibility to the
consumer, and if we were to shirk that
responsibility, we would quickly be out of
business. Food safety is first and foremost in
our interest as businessmen.
I think we have already implemented various
and sundry things. We developed a guidance
document for the industry on our own and put our
own efforts into doing that. We have implemented
those. We have very, very diverse conditions
under which we produce the fresh fruit and
vegetables here in the United States.
We have been talking about the possibility
of drip irrigation, microjet irrigation, Chip
talked about furrough or drip irrigation, citrus
could be on seepage irrigation.
In the vegetable community out here west of
town, we literally manipulate the water table
just by raising it to a level each crop needs.
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The water doesn't go over the top of the crop; we
put it in the root zone where it needs to be.
Now, how do we do that? We do that by
raising our water table out of surface water
canals. And someone suggested that we perhaps
cover that surface water canal? I know I'm being
facetious, but probably the pond that we're
watering out of encompasses thousands and
thousands of square miles of surface water. It's
impossible to do.
I don't want to stand up here and pick apart
your efforts, but I do want to encourage you that
this is, as Chip pointed out, the most opportune
moment that you're going to have to impact these
guidance documents that will continue to affect
us long after your names are forgotten.
So please move forward slowly and consider
very carefully the very diverse industry that
you're impacting because we are regulated,
whether it's by the government or whether it's by
the buyer that I mentioned earlier this morning.
And I'll go through a few of these. On the
irrigation water; this is one that causes me most
concern. Evaluation of the runoff. Our water is
runoff, all of it. We gather that water and
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reuse it, and have to by permit. Tail water
runoff is recirculated, it is open to the
environment, which you might also consider is
inhabited by endangered species, and they tend to
like the farm; they don't like cities. And we
can't regulate where they're going to use the
bathroom, whether they're aquatic or whether
they're birds or whether they're mammals running
around on the ground. I can share your concern;
I hope you can share my frustration.
Spray water. We may be seven miles from the
closest utility line, so there's not a pump
there. We're pumping water right out of the
canals, and that is a common operation.
The reclaimed water that has been mentioned.
The reclaimed water -- and I'm going to go ahead
and talk about sludge, municipal sludge at the
same time -- is very, very closely managed by
other federal and state and local regulations,
and if they aren't meeting their standards, our
use of it is just improper, and it is used in
certain small limited areas, but it is used. So
I don't want to downplay the idea that municipal
sludge is used, or downplay that reclaimed water
is used because it is, and will continue to be.
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But it's under very close guidelines already.
Processing water. I found it very unique
that you use potable water there -- use that
term. That sounds good and looks good on paper,
but there may not be a source of potable water of
sufficient quantity to do all the things that we
do. And I'm talking about everything from
cleaning equipment to cleaning the packing house,
washing the produce, as you intended it to mean,
to irrigation, not to mention the makeup of water
that we use for spraying.
Wash water, the addition of sanitizers. We
already are doing that, but I'd like to
perhaps -- it may be unnecessary, but to -- since
I didn't see some of you on the field trip a year
ago, two years ago this coming January, I'd like
to educate you a little bit with regard to water
and sanitation, because I think you're thinking
about a packing house, and I'm thinking about the
packing house may be the field. The entire
field. How do I sanitize 40,000 acres? That's
just ours; not to mention my neighbor's.
We use chlorine in the water that we wash
the bugs off of the celery or the leaves as we
cut it and pack it in the field. That's one
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method of packing those commodities. They may be
harvested in bulk and brought to a packing house
and treated as you are probably thinking, at a
packing house. But I wouldn't say that the
majority of the acreage in the United States
comes to the packing house unpacked.
So chlorination or addition of sanitizers is
something that is done in a limited way. It may
not get washed at all. How would you overcome
the dilemma that I'm certain -- and I haven't
seen a farm in about three weeks, at least not
one that we have; I did try to take some
vacation -- but we have we had three and a half
inches of rain on the west coast yesterday and
you talk to me about clean boxes and equipment?
I'm certain it was fairly dirty, and I am certain
that if we didn't get in a crop out of the field,
it would be lost.
We cannot assure pristine, clean operating
conditions because we operate under God's
environment, subject to everything that gets
dumped on us. And it could be muddy. We clean
the produce, we clean the equipment, and we
provide clean boxes.
Soil types can impact this tremendously. If
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you have sand, you can get it off relatively
easy; if you have muck, you can get most of it
off, but the residue looks worse when it's left
on there because of the cold. And if you have
clay, God forbid, it sort of collects water. So
the more water you put on it, the muddier and
messier it gets. So I just want to caution you
about some of this.
The temperature differential. If we
increase the temperature, we will have more
diseases on that produce by the time it gets to
the consumer than we will if we chill it very
quickly. That is not practical. It may be in
the lab, but it is not in the real world.
Worker training. We have OSHA standards, we
have worker protection standards, we provide hand
washing facilities to them, we have -- we have
the bathrooms in the field, we have training
programs for hygiene, the smoking, the heating,
the air, all of this, depending on where you work
and what you do, we have training programs out
there that are available. And I'm not talking
about A. Duda & Sons, they're available to all
the growers that want to use it and want to go
and train their people. And I think the -- most
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of us are implementing those ideas already.
Maintenance and sanitation I just touched on
a while ago. I don't know how you keep
everything pristine clean in a field condition.
Animal control. I would love to be able to
get some of them out of there. Deer eats the
crop. And a lot of others cause serious problems
that I can't do. But I am regulated by other
government agencies that says leave them alone.
And I want to point out also that I am
disappointed that we have a guide to minimize
microbial food safety hazards for fresh fruit and
vegetables, it's open-ended. Where did it begin
and end? It began out there when we prepared the
land and it ended when we put it on the truck.
That's all I have control over.
But as I read the newspaper and as I listen
to people who can talk about things that I don't
know enough -- don't understand; I'm not an
epidemiologist, I find a lot of it is traced back
by scientists and experts in the field through
epidemiology to cross-contamination, and I find
that it happens somewhere other than the farm.
I understand your concern; I understand you
have to address the issues, but I don't see where
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we've talked about trucking, I don't see where
we've talked about warehousing, I don't see where
we've talked about that grocery store chain or
the consumer coming by, as someone said and I
found amusing, fondling my produce. God only
knows whether they sneezed or went to the
bathroom before they did it.
Positive lot identification is something
that's impossible. It's a cost. I hate to put
it that way, but I would ask the buyer again,
what are you going to pay me to put it on there?
We operate maybe three to five percent return on
our investment. Most of you wouldn't invest your
money in the stock market if that was all you
were getting, or any kind of municipal funds or
anything else. You pull it out of CDs because
you can't get any better than we farmers get, and
I do the same thing.
But when you pass this on to me, I can't
pass it on to him. It just eats into the profit.
We were talking about being profitable here
earlier like it is possible. It gets harder
every year. I've been at it for 25 years and
every year it gets harder than the previous year.
Chip used the term, and I liked his term,
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perhaps if I had avoided it, I wouldn't have had
my outburst this morning about guidance.
De facto regulation. That is exactly what this
will ultimately end up being.
And I'll finalize by saying, this is -- and
I'll repeat it -- this is your only chance to
have any impact on the GAPS that you're going to
develop, and once it's out of your hands, by
de facto regulation, I'll live with it for 11
more years.
MS. ISAACS: Thank you, Dr. Beasley.
I should have mentioned earlier, if you do
have written testimony, to please leave at least
one copy with us at the head table.
And now we'll hear from Mr. Dan Riche with
Riverfront Groves, Vero Beach, Florida.
MR. RICHE: Thank you.
When I got the call from Richard Kinney,
(phonetic) the executive vice president of
Florida Citrus Packers, I got the call and he was
being very complimentary and asking me about my
children and taking a genuine interest in me, and
I pulled a chapter out of Dale Carnegie's book,
and I'm thinking, all right, Richard, what do you
want, because I knew there was a reason for this.
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He told me a little bit about what this was
about today, and I'm a farmer, and I'm a packer,
I'm a marketer, shipper; I'm not a PR guy, I'm
not a very good public speaker, which you'll soon
see. But I also know that Richard has a wife
that I knew in college, and she has, as I think
Mohammed said, divinely -- what was it,
Mohammed -- divinely -- she has a divinely
developed memory, among other things. But a
divinely developed memory of my college days, and
I knew Richard had the opportunity to blackmail
me, so I had to agree.
Also, I'm surprised he asked me. Last time
he asked me to do this, we went to a
congressional delegation and spoke to the group
about NAFTA, and I was sitting there with my time
and I'm making good eye contact with everybody,
all the important things of public speaking, and
I was getting a little cocky. As I looked down
the line, I noticed one of the congressmen was
sound asleep, so that was a real blow to my ego
and I swore I would never do this again, but here
I am.
My name is Dan Riche, I am the President of
Riverfront Groves. We are a grower, packer,
187
shipper, and marketer of fresh citrus. We employ
about 200 people from the field right on through
the packing house.
One of my many non-paying jobs right now
also is I serve as president of the Indian River
Citrus League, which is a trade association of
1,600 grower members stretching from Palm Beach
to Cocoa Beach. We have approximately -- in the
State of Florida, we have approximately a hundred
packing houses that employ plus or minus 15,000
people.
As we said -- one of the benefits of going
last is a lot has been said, also. Certainly,
the goal of food safety is a worthy cause;
there's no argument about that. Our company, we
ship to both domestic and export markets; as a
matter of fact, 65 to 70 percent of our product
goes offshore into the international market,
purely because that's where the higher FOB's can
be derived and, right now, as you probably are
aware, in the last four or five years, citrus has
been in a very difficult state economically.
Under GATT -- and I've been involved with
Richard and Bobby and some of the others
regarding the opportunity to expand our
188
markets -- and under GATT, we're dealing with
Australia or Mexico or China, trying to gain
access, and all of the discussion of access
pretty much the preclusion of our fruit, has
always been science based.
This situation here, I believe, could cause
our trading partners to react negatively if we
eventually endorse and publish this type of a
document. Even if it's guidance -- and I'm going
to echo several of the former speakers -- even if
it's guidance, it's publicity and it's perception
that makes a difference.
The best example that I could think of in
that regard was the Alar scare in Korea several
years ago; the Alar and apple industry in
Washington. Well, Alar is not labeled for
citrus; it has no use at all for citrus. Yet the
Korean press picked up and stated that Alar was
applied to citrus and we lost our market over
there and have yet to recover the same volumes.
Again, it's perception, it's publicity.
These are the type of things that can come out of
these type of guidance regulations -- I'll call
them regulations because I believe that that's
truly what they do become. The damage was done;
189
there's nothing we could do about it. We lost
our market share, we lost a lot of money.
Another example of an experience that I
personally had was the United Kingdom market on
citrus. Sansbury is a very large importer in the
UK. Sansbury came through Florida and said they
wanted to import citrus direct; they no longer
wanted to go through an intermediate handler.
They came to several packing houses, they came
with a set of documents that they were going to
say -- that they indicated that were going to be
imposed upon us with food safety.
They weren't unreasonable, totally; some
were, and they realized that. And the fact of
the matter is, though, they went back, they --
they indicated it was just guidance. They went
back, and then following that guidance discussion
came this very long legal document that they
required us to sign stating that we would adhere
to all those.
My question back to them was, well, you came
and you said this was guidance and we were
supposed to make every effort to adhere to this
guidance. Well, it became regulation and it
became very difficult to the point that Sanisbury
190
didn't get any fruit direct for a while because
they had to abandon that because we couldn't
adhere to those requirements.
The quote was made earlier that the
agricultural industry is a very complex one, and
it came from -- I'm not sure, I think maybe
Terry. That is very true. There is no broad-
brush approach that's applicable to our industry.
Fresh citrus, as Bobby and Mohammed said, is
an extremely safe product. We have no
documentation of any problem with our product
with food safety. And as some of the other
speakers said also, we are very apprehensive at
the speed at which this is progressing.
I find it a little interesting about the
timing of this also. The President's Initiative
came out October 2nd. I find it interesting that
the timing of that was just prior to the fast
track vote, and the possibility that this could
have been a preemptive strike against the fast
track opposition, which certainly might use food
safety as a battle cry.
Food safety is an absolute objective of our
industry. Hudson Foods is an example of why we
cannot take risks with our product. Hudson
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Foods, to my knowledge, is no longer in business;
if they are in business, they're not anywhere
near what they were.
There is no compromise on food safety in my
organization, and I know there is no food safety
compromise in our industry.
I mentioned the apple industry and Alar,
there is a lot of people went out of business;
there was really no basis for that claim, as you
know. The recourse that we, as growers, have or
they, as growers, had, they filed in the State of
Colorado, yeah, they probably won, but the damage
was done. The horse was out of the barn at that
point. The door was shut, the horse was out of
the barn. The damage was done, the economic
damage was done. So perception, again, in
reality.
Someone also said, it's difficult -- it
would be difficult to take this type of language
and turn it into requirement. Well, I can tell
you that is not true. It's not difficult for the
buyer to take recommendations or guidance and
turn them into requirements. And in our industry
any more, the supply side of the equation is much
more fractualized than the procurement, buying
192
side. And it doesn't take much intelligence to
know who's got the strength and who doesn't.
So in our case, if this became a requirement
of our buyer, we would have to meet these, and I
readily believe that this will be something that
they will be looking at.
Another, you know, words like -- on that
subject -- words like minimize and avoid where
feasible. They just get blocked out and they
become requirements. I know the intention is
good and have all due respect for everyone who
drafted this, but I think this is the time and
this is why you have this forum for this type of
dialogue.
Perception, again. I'll take a minute to
talk about perception and -- in another sense.
Irradiation and cold treatment are two viable
ways for us to move fruit to Japan, yet the
customers won't take it. Irradiation for obvious
reasons, and cold treatment for other reasons
that are not founded. But it's the perception
that the two of those do not work that we do not
ship to Japan under those means of protocol.
Again, it's a reverse, but it's perception.
I really think what it boils down to is what
193
you are intending to achieve and what you will
achieve are not the same. As I mentioned
earlier, also, we also have constant challenges
to gain access to markets. Currently, we're
dealing with China, Mexico, and Australia; this
would definitely be some new information for them
to latch on to to continue to put some non-tariff
trade barriers in front of us.
On the public side, the public perception in
our own country arguably could cause a concern;
it could cause our population to move away from
fruits and vegetables due to a fear, an unfounded
fear. This could defeat all of our recent
objectives to encourage a healthy diet, including
more fruits and vegetables.
An example of that would be the Chilean
grape scare several years ago, where we had one
or two grapes that were tainted. And I would
venture to say, just like the strawberry industry
was affected dramatically by the recent outbreak
from the Mexican strawberries, that the
Chilean -- or the domestic grape business was
severely impacted by that. And there's a lot
of -- a lot of concern regarding that.
In closure, I do believe in my heart that in
194
your heart that you're doing the right thing, and
I believe it's a noble cause. Our industry
specifically is fighting for survival. The
economics of our business the last few years have
been extremely difficult. We don't need this
type of curve ball thrown at us at this state in
time.
I would respectfully request that you
consider slowing down the process. I understand
fully the time line you've been presented by the
President, but I also understand that time lines
have come and gone many, many times before this
one, and I would request that you -- you request
an extension, if necessary, and please involve
the portion of the USDA with the FAS and how this
will affect us on the export side of our market,
because I can tell you, the citrus industry,
fresh citrus industry, would not be surviving
with the economic state we have if we didn't have
that one glimmer of hope that we have, and that's
the export.
There's too many questions at this time and
too many possible challenges that could be thrown
at our feet. Again, I know you believe in your
cause of guidance and I respect that mission, but
195
I do believe, in closure, that the impact will go
way beyond your intent.
Thank you again for your time.
MS. ISAACS: Thank you, Mr. Riche. And now
we'll hear from Mr. Wes Roan with Six L's Packing
Company, Incorporated, Immokalee, Florida.
MR. ROAN: Thank you very much for the
opportunity to be here and welcome everybody to
sunny Florida, at least it is today. It wasn't
yesterday, but it is today.
Again, my name is Wes Roan. I'm the
director for research and development in
vegetable production for Six L's Packing Company.
We're located in Immokalee, Florida. We're a
fresh market vegetable producer, specializing in
tomato and pepper production, packing and sales.
We're a corporate family farming operation; we
farm in Florida, Georgia, South Carolina,
Virginia, and Pennsylvania.
Recent impact of microbiological
contamination of imported agricultural product
seems to created a sense of doubt in the minds of
the current administration and some consumers as
to the reliable health benefits of fresh fruits
and vegetables in the American diet. The
196
benefits of five servings a day of fresh American
grown fruits and vegetables will always far
outweigh the risks of potential food-borne
illness.
The quality and safety of our products plays
a major role in our ability to be profitable in
competitive global marketplace. Microbiological
food safety issues and best management practices
to minimize risks of that nature have been and
will continue to be a management strategy for the
success of our company.
Some of the concepts we currently
incorporate into our production and packing
procedures for the mitigation of microbiological
contamination include field -- production field
sanitation facilities for harvesters and
laborers, chlorination of field packing and dump
tank equipment, selection of commercially
produced fertilizer products, the use of drip
fertigation technologies, and the use of plant
disease specific crop protection chemicals.
A lot of these issues we've talked about, a
lot of the speakers have reiterated them, and
I'll probably say a lot of the same things. But
one of the issues that we face in the field in
197
the production scenario is the availability of
water and the limitations put on us for the
amount of water we can use and, in some
instances, the water quality.
We have lots of different water sources,
sometimes many different sources on the same
farm, depending on the location of the land,
whether it's owned or rented; it might be surface
water, it might be well water that's pumped from
the ground and pumped into a pond which then is
then pumped to the field because we don't have
access through whatever limitations to pump
directly from the well to the field, so we have
to pump over the middle of the night to gain the
volume of water we need and pump it into a pond,
and then, in daylight hours, when the crop needs
the water, pump it through the systems that we
have, primarily drip irrigation in these
instances.
Also, others have talked about animals and
the control of circumstances that would lead to
these types of contamination. Well, animal
control is impossible. Everybody knows that
there are rats and mice and raccoons and deer and
pigs, and I don't care how large your fence is or
198
how electrically charged it is, it doesn't keep
them out. You know, you can go out in the field
and be looking at your crop and you'll find birds
nesting in the crop; stake tomatoes are a prime
location for bird nests.
We have a situation in Naples right now
where we're dealing with a bear and its cub. And
this bear has decided that it likes our
watermelons and it likes the things that we have
to offer in the field better than what's in the
woods. Well, we called the Game Commission and
they say, well, gee, we're sorry, it's just a
bear and, you know, you're going to have to live
with it.
And the old saying that we use when we're
pretty sure of something is, does the bear do
what it does in the woods, and I can tell you now
that he also does it on the farm, too. And we
can't control that any more.
And not only did this bear come on the farm,
but he's right in the middle of a residential
area, and it doesn't seem to matter; the bear has
free reign and we don't have control of the
animals any more.
Okay. Our packing houses, we have
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facilities that employ sanitation management
procedures, including constant testing and
documentation of chlorine levels and dump tanks
and flumes. The use of new packaging and
palleting materials at all times, personal
hygiene training and monitoring of packing house
employees.
Other recently incorporated product
management techniques, such as positive lot
stamping for track-back identification does allow
for a certain amount of track-back of our
products, but we do face the problem that, once
our product is purchased and sent on a truck, it
may go to a direct consumer, it may go to a
re-packager, and once it's out of our hands, it
can be -- I guess the word was intermingled with
many other sources of product. So it does allow
for source of -- origin information, but it can
only be effective while it remains in our
packaging.
We talked about education. We talk about
education to our workers, but we've also talked
today about education of the consumer and
education of the handlers off the farm. I
believe that consumer education is probably the
200
biggest and most important area that we could
improve upon.
I know from my own personal experience with
eating in my own household, eating at friends'
houses, the different things that people take for
granted or let go as insignificant in the
preparation and handling of food is, a lot of
times, something that concerns me, and I try to
always educate my friends and my wife when I have
a chance.
The loss of control of our product in the
transportation process is of critical concern to
us. We are at the mercy of the end receiver
perspective of what the quality of our products
are. And a lot of times, temperature control in
the transportation mode is the main reason for
those problems.
We're forced to spend money in management
and control of temperature logging units that go
into the transportation vehicles to justify and
verify that the temperatures were maintained as
the transporter indicated that they were; it's
not just his word against ours, we now go ahead
and document through data loggers temperatures
from one end to the other.
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Sanitation is real important at the -- we've
talked about it -- at the retail markets. The
fondling issue is very funny and -- but it's so
true. How many times do you, as a consumer, go
in and you grab that cantaloupe and you want to
feel it or maybe you pick it up and you sniff it,
or you grab that tomato and you squeeze it. It's
just so common.
And all of the risks and the potentials that
come in with the consumer are hard to ignore, and
probably where we should be focusing a lot about.
Six L's Packing Company will continue to
implement management strategies that minimize the
potential for microbiological contamination as it
makes good sense. I hope that in an era of
regulatory actions that impact the way we manage
our labor, the chemicals that are available for
our crop protection, the availability of a water
supply, and the constant onslaught of
environmental lawsuits that attack farmers as
polluters of the community, our legislators will
find wisdom and use their strength in coming to
grips with the realities of microbiological
contamination.
There are currently many laws that impact
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issues that affect the potential for food-borne
illness. Jumping into the rapid escalation of
government guidance documents and/or regulatory
action without due diligence and attention to
sound scientific data will only exacerbate the
financial burdens to American agricultural
producers.
Thank you very much.
MS. ISAACS: Thank you, Mr. Roan. We are
going to participate in a five-minute break. We
have four official industry presenters yet to
present.
Dr. Malecki, what time did you have to leave
by?
DR. MALECKI: I have to leave by 3:30.
MS. ISAACS: 3:30? Okay. If it's okay with
Camille, I think when we come back, can she give
hers and then go back to the industry and then
continue with the stakeholders?
Okay. Be back here by 3:00, we'll give you
eight minutes, and there's some drinks left
outside.
(Thereupon, a short recess was taken.)
MS. ISAACS: Okay. As I mentioned, Dr. Jean
Malecki, she's an M.D. and has also has a
203
master's in public health. Dr. Malecki is the
director of the Palm Beach County Health
Department, and we're just briefly interrupting
the industry presentations for now because she
can only stay here for a little bit longer
because of a conflict.
So come on up, Dr. Malecki. Thank you for
joining us.
DR. MALECKI: I am going to show a couple
slides. I don't know if you'll be able to see
the overheads.
First of all, welcome back from lunch, and
most of us had a lunch of chicken, rice, and
beans, and still we're back here with our
behavior habits talking about the health of fresh
fruits and vegetables. I just say that because
am a proponent of fresh fruits and vegetables.
First of all, just a few comments before we
turn the lights off. I am a public health
official for this county. I have been involved
in what I call enumerable outbreaks related to
food products from contaminated spice with
specific bacteria, and not necessarily because a
spice had bacteria, and spice do, but because of
improper cooking of the spice, all the way -- and
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that was in a major hotel here in Palm Beach --
to an outbreak of Hepatitis A related to little
kindergarten children taking jellybeans off the
table of a kindergarten teacher and transmission
that way. So I really do appreciate the comments
that I've heard that from farm to mouth is
extremely important.
Welcome to Palm Beach County, the diarrhea
capital of the world. And that marks my career.
Our Margarita y Amigas' Salmonella to cyclospora.
In fact, just recently, the press decided that I
should start a new sitcom for a new network
coming into being on Paxson, and it's supposed to
be entitled Diary of a Medicine Woman. And
that's for real.
And we also, because of the situation,
especially with cyclospora, have Boca Raton, one
of the, you know, wealth capitals of the world
next to Palm Beach, called Bocarrhea. So we
really -- you know, we really consider this very
serious. And I'd like to say that we have the
cleanest colons in the United States.
With that, my comments today are going to
outline what we went through in investigating
cyclospora. Back in 1995, Palm Beach County
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really was the major county that initiated
investigation of this, what we call, emerging
health threat. A disease caused by a parasite.
The parasite actually is in the slide there, A,
it's the largest one, and this is one which
really was unknown to the United States back in
1995, unless you traveled abroad and you consumed
water or produce abroad in countries where this
is endemic. Otherwise, we didn't see it here.
But in 1995, we did because we were looking
for it. We had a laboratory and hospital down in
Boca who actually had a medical director who came
from Peru, who did a lot of work in Peru, knew
about cyclospora, saw travelers with this, and
actually trained the laboratory technicians in
identifying this. Otherwise, this would have
gone undiagnosed.
At the same time, a smoking gun was
occurring in New York. Certainly not as vast in
the outbreak as in Palm Beach County, but one
which really substantiated some of the findings
that we found in 1995, and then further on into
1996.
I show the organism to you because our
discussions today have dealt with the safety of
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the fruits and vegetables and the importance --
and I want to stress this now and at the end of
the few minutes I'm going to speak -- the
importance of research in microbial standards.
And when I'm saying that, I want to say microbial
identification.
We were at a loss in this county, we were at
a loss world-wide because this was an organism
which was basically an unknown and an emerging
health threat. Very little research had been
done on it. And, in fact, to today, we do not
have a sensitive and specific test to isolate it
off produce.
We certainly are better at it looking at it
in humans and looking at it in stool, but we
still are at loss. Is that uncommon in public
health? No, not at all. In fact, the
investigation and promotion and intervention of
almost all of the major health threats that we
have seen known to man have been corrected
without identifying the cause of it.
If you go back to the studies in England on
cholera, typhoid, no one can isolate those
organisms. In fact, our earliest intervention on
HIV, the largest cause of AIDS, were done and
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implemented prior to our isolating that virus.
So I say that to you as industry, as
stakeholders and people who are charged with
public health, that the science of epidemiology
is extremely important, even if you can't isolate
the organism, because I will guarantee you, the
laboratory science falls behind, and it still
does with this particular organism.
One other thing that you should know is that
we, at public health, like to say, cook your
meat, right? Wash your fruits and vegetables,
because we all know there will be some form of
contamination. A good scrubbing here and there
does you a lot of good. This organism is a
sticky organism, and how many of you really can
thoroughly scrub those wonderful beautiful
berries that are very pliable and very fragile.
So knowing the microbiology of the organism
helps you, helps us in public health, and really
to give a good public health message.
This -- I do need to go over there, but I'll
describe this because it's important when you're
investigating an emerging health threat,
especially one which has been imported. And my
comments are going to be totally isolated to
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importation, and I want you to be aware of that.
As you could see here, we're comparing the
1995 outbreak to the 1996 outbreak. The 1995
actually is a diamond shape and they're purple,
and the 1996 are orange colored and they are in
circular color.
When the outbreak occurred, it occurred in
Bocarrhea, or Boca Raton. I say that because,
when we were investigating this for public
health, we did everything possible; we
interviewed every patient and their family, we
went to every restaurant -- and let me tell you,
people in Boca like to eat out -- we investigated
every grocery store, we went to every
distribution center, and I personally watched the
trucks come in. All right? From across state to
the distribution sites. And we knew -- and we
knew early on, it did not occur here in this
county and the contamination did not occur in
this state.
So by doing that and by looking at the water
supplies, number one, the water supplies, we were
able to begin to hypothesize. Eventually, it was
not just an isolated event in wealthy Boca Raton,
which was a clue to this whole thing, because
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people without the money can't purchase those
beautiful, beautiful berries that come into the
State of Florida, at that particular time,
they're very costly, and there is what's known as
market share. And as you know, there's a
distribution based on cost and based on beauty
and based on taste to those areas of the country
where people can buy them. So lo and behold, we
began our outbreak.
Will you please give me the next slide?
Because of the lack of laboratory science,
the unknowns, we identified in 1995, 41
laboratory confirmed cases. Is that all we had?
Absolutely not.
And by the way, this is probably happening
all over the country, but nobody was looking for
it except for us.
And, as you can see, when we were looking
through this, we did have two events; everybody
dreams of an outbreak of a single event, and we
eventually were looking at strawberries and at
raspberries and began tracebacks with our
partners, our distributors, and that's where the
trace back began, which is now called lot
identification.
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I think this is a very important point, and
I'm going to raise it right now, and I'll
reiterate it again in my comments. But the
industry, as a whole, federally, we have to come
to grips with being able to truly traceback to
the farms. That's where the identification of
contamination must be. Remember, I'm talking
about imports. Because the contamination here
really did occur at the farm site, and if we
can't trace back to those farms, there is that
commingling in the packaging piece, and if we
want to save an industry and we want to be able
to have a single voice as to a culprit, then we
must be able to do that. And if one piece of
industry has to go blind, but let's not have the
whole apple industry or the whole raspberry or
strawberry go down the tubes.
May I have the next slide, please?
The conclusions of the 1995 with an
epidemiological study with the CDC pointed to
soil contamination and possibly raspberries.
In 1996, because of the awareness that
occurred, we certainly notified all my
compatriots throughout the United States, other
people were ready to pick this up.
211
Most of you remember the Houston media event
that took place. We had 108 laboratory confirmed
cases. And, again, we looked at clusters, we
looked at confirmed cases and, in this particular
time, as also took place throughout the United
States, pointed to Guatemalen raspberries.
What's important -- and this has to do with
partnering, and this has to do with consumer
awareness and both of those terms have been
mentioned. When we have demographic evidence, as
we had in 1995, it is certainly important to
actually apply what we call the basic science of
public health, which is epidemiology, knowing
full well in these types of situations, you might
not uncover the actual cause of the organism, but
based on statistics, you can really point your
finger, and you can really find a culprit and you
can find provide interventions and
implementations.
You get the statistical evidence in here; it
was raspberries, and it was very specific to
Guatemalan raspberries and, as we moved forward
with this and we did our tracebacks, it was
difficult to go back to the farm.
And as you know, CDC went over there, I
212
think FDA went over to Guatemala, and they did
attempt to initiate changes over there at the
farm site; hygiene, sanitation, there was water
that was contaminated, they actually had
risked -- had a risking level from one, two,
three, four, in terms of the farms and when they
could export and when they could not export fresh
versus frozen raspberries versus no raspberries
at all. It was either a complete HACCP or a
modified HACCP approach. It didn't work. It
didn't work.
We relied on an existing environmental
evidence, which is weak right now, which is one
think everybody in this room has to support. If
we can do tracebacks back to the farm without the
commingling, I think the industry and, most
importantly, the public will be better informed
to make wise choices and important choices in
their diet.
In terms of epidemiological evidence, we can
no longer avoid or put our heads in the sand the
strength of that evidence. It's three years
later, and we're seeing this product come out.
I, too, because I'm a public health official
and I specialize in prevention, I want everybody
213
to eat fruits and vegetables. But I also want
them safe. So I want both and I want them now.
Next slide. Let's go to the next one.
MR. BARNES: That's it.
DR. MALECKI: That's the end of it? Okay.
Let me go ahead and summarize. Evidence.
Again, evidence on sampling, evidence used
epidemiologically and statistically. We still
cannot isolate cyclospora from fresh produce,
whether it's Peruvian lettuce, lettuce from Peru,
raspberries, basil, whatever it might be. But
there are indicator organisms, and I would like
to see this panel address that.
We know when there's contamination. We
don't have to have cyclospora on a piece of
lettuce to know that. There are indicator
organisms that you use in your industry, such as
E. Coli. And I think if you start looking at
sampling, whether it's a guidance issue or a
regulatory issue, E. Coli is an indicator of
contamination. And I suggest to you, that could
be of use in terms of sampling produce that comes
into this country.
Positive lot identification. This is a
cooperative issue, and one which us, as a public,
214
in making our choices whether to choose
raspberries from the State of Florida versus
raspberries from Guatemala, versus specific
farms, is extremely important for us.
Perishability of the produce. And when
we're looking at where can we identify, where
should we test, you've got to go back to the
farm. When you're investigating a disease like
cyclospora which has an incubation period that
can range up to 22 days, and I'm relying on your
memory to tell me what you ate even two weeks
prior to that, how many of you can tell me what
you ate two days ago? Then to go back to the
shelf to get that same raspberry batch, it's not
there any more.
So I agree with you, and I wholeheartedly
support, that if we are going to look at
continuing to import from areas where we know
there's contamination and we want to provide
technical assistance, then we have to go back to
those farms and work with that contaminated water
and work with those folks; not here in our local
supermarket.
Educating the wise consumer. I think we've
been in the forefront in the State of Florida,
215
and I commend the regulatory agencies, to ensure
and implement, make sure that there's labeling in
every one of our grocery stores so that people
can choose; they can choose what they want to buy
and where they are buying it from.
And most importantly, research and
development. This is not just research and
development in terms of microbial standards for
produce; this is research and development on the
medical side of the house as well. They can't be
separated. They're intertwined.
So the partnership that we have has to
remain there. There has to be a trust factor,
and we have to be cooperative in our approach in
the future.
So with that, I want to say thank you for
allowing me to present this. I certainly applaud
the efforts. It's been three years in coming.
know some of you think that there's a delay here.
As far as I'm concerned, I would like to move
forward, and certainly move forward
collaboratively. And, again, these are comments
made on importation.
Thank you.
MS. ISAACS: Thank you, Dr. Malecki.
216
Now we will go back to the industry. Some
folks had signed up to give short presentation
testimony. J. Luis Rodriguez. You're with the
Florida Farmers & Suppliers Coalition?
MR. RODRIGUEZ: Yeah, I'm willing to yield
my time to Mr. Smigle, because he wants to make
visual presentation of a short documentary that
we have.
MS. ISAACS: Okay. Gary, did you want to
come up here?
Okay. Gary Smigle, president of the Florida
Tomato Exchange, and you're based out of where?
MR. SMIGLE: Lantana.
MS. ISAACS: Out of Lantana. Okay.
MR. SMIGLE: My name is Gary Smigle, I'm
president of the Florida Tomato Exchange. I'm
with Mecca Farms; we farm on the East Coast of
Florida, primarily winter vegetables. We're a
family farm and business. We've been in
operation just at 100 years.
We're unalterably opposed to this initiative
and to the guidelines, and I'll tell you why
briefly.
When I first heard of the President's
Initiative I said, great, he's finally come
217
around. It seems like every three months over
the past two years myself, Mr. Rodriguez, I've
seen Mike Stuart, many, many people from our
industry have been up in Washington asking the
government to push a country of origin labeling
law.
We think there is a problem. The problem is
not in the United States farmers; the problem is,
as the doctor just told you, that we see it, is
Guatemala, it's Mexico, it's the people that now
produce 60 percent of the winter vegetables eaten
in the United States.
These countries routinely use practices that
wouldn't last a minute in this country, and then
they have free-flow of all that produce into the
United States where it's not labeled, where the
consumer does not have a choice, and where we say
people are getting sick.
We, too, deal with the 46 government
inspectors, some days it seems like twice that
many. We don't need another government
regulation on us until we cure the primary
problem.
Before the program closes out, they've
agreed to show our documentary, it's 12 minutes
218
long. We sent a film crew to Mexico to document
the sanitary practices there and we would invite
you to look at that.
Thank you.
MS. ISAACS: Okay. Thank you, Gary. That
video will be shown when we wrap up our session.
If we go, you know, until 4:00 o'clock or after,
for those of you who want to stick around.
Did Dr. Malecki leave? She wound up with
one of my business cards, so I may not call
everybody who signed up here, so speak up if you
don't get called by the end of the day.
Okay. Next we will hear from Mary Dettmers
with PBC Greenmarket Association.
And, Mary, where are you from?
MS. DETTMERS: I'm from Jupiter.
MS. ISAACS: Okay. From Jupiter, Florida.
MS. DETTMERS: I am a master gardener
trained here at the Palm Beach County Extension
Service, and also serving this year as the part-
time director of the Palm Beach County
Greenmarket Association.
And I wanted to draw to your attention to
something that's happening here in Palm Beach
County that I think is very relevant to the
219
discussion today. We're talking about from the
farm to the table, the safety of the food.
Obviously, the quicker you get from the farm
to the table, the safer the food is; the more
direct the route. And here in Palm Beach County,
the agricultural community and the government
have joined together in a very proactive movement
to provide local produce to the local population.
We have a group here called the Agricultural
Enhancement Council. It's representatives from
different parts of agriculture who are advisors
to the Palm Beach County, Board of County
Commissioners. They've been in existence just
two years and, in that time, there's three
projects that they've done that I think could be
imitated country wide.
The first is, ask where it's grown. This is
just one of the posters; there's also bumper
stickers and other literature. But ask where
it's grown. We are educating the local
population to ask where the produce comes from.
Recently, the Palm Beach Post reported that
60 percent of the people nationwide don't care
where their food comes from; it's not even a
question, they never thought about it, it doesn't
220
matter. Well, it does matter if you're trying to
get the food from the farm to the table in the
quickest possible way so that there's less
opportunity for any contamination.
Obviously, if you think about it, it
matters. And so our agricultural community,
which we must say is a wholesale agriculture
here; we're the biggest agricultural county in
the Eastern United States, and it's 99 percent
wholesale, in other words, shipped north and out
of state. Nevertheless, the farmers here
recognize that it's time to start creating
avenues for their produce to get to the local
population.
So in addition to this educational program,
they have provided support for the Palm Beach
County Greenmarkets, which are open-air community
markets that have just sprouted up, again, within
these past two years.
The first one was started by Mayor Graham of
West Palm Beach, a very strong mayor who believes
that local produce is best for the health of the
people, and that an open-air community market is
one of the best ways for people to gather.
Well, our Agricultural Enhancement Council
221
supported that effort by creating an association
of any greenmarkets that started. In two years
now, we have seven community markets that are --
come right down the coast of Palm Beach County,
all in an effort to make local produce available
to the local population.
And then the third of the projects, just
briefly then, is the growing tours. The Ag
Enhancement Council has supported tours whereby
they're taking tours by the bus load and local
people to the farm so they can find out what is
being grown here in Palm Beach County, what are
the standards by which our food is being grown,
and educating themselves about what the food
supply is.
All three of these are aimed at shortening
that distance between the farm and the table.
And, you know, as a master gardener, we work with
people all the time, telling them how to create
habitat for all the different species; how to
plant blue porter wheat so you get butterflies in
your yard, you know. And, meanwhile, in Palm
Beach County, we watch our food supply, the human
food supply, being outsourced to Mexico and
Central America and other countries.
222
Not to say anything bad about what's grown
in other countries, but it's a principle of
ecology that you keep the food as close to the
species as possible, and that's what the people
in Palm Beach County have been trying to do
through this cooperative effort of the
agricultural community and the government.
And just this week, the Department of
Agriculture from the state, the State Department
of Farmers' Markets, agreed to give us signs for
each one of our seven markets that have the big
"Fresh From Florida" logo on it, and the support
of Bob Crawford and the Department of Agriculture
for this effort.
Thank you.
MS. ISAACS: Thank you, Miss Dettmers.
Next we have A. Roswell Harrington with
Florida Organic Growers.
A VOICE: He had to leave.
MS. ISAACS: He had to leave. Do you know
if he left any written testimony?
A VOICE: No, I don't.
DR. TROXELL: We'd appreciate hearing his
comments if he'd submit written comments or
something.
223
MS. ISAACS: And, in fact, I should have
mentioned this earlier. I was told around break
time that the announcement that we formerly
alluded to this morning that it was in your
packet that told you how to submit your written
comments, for some reason, was not in the packet,
so Camille has had copies made, and please pick
one of these up on your way out so you can submit
additional written comments, and be sure to use
that docket number on here.
DR. TROXELL: And let me say right now, the
comment time frame in there, I believe, is
December 19th. Please don't hesitate to send
comments even if you can't get them in by
December 19th.
There is going to be plenty of time through
December and beginning of January to get comments
considered in our next phase of this project, and
we really would like to see written comments so
we can think about what you all have to say.
MS. ISAACS: Okay. Thank you.
All right. Al Yamada? Is that right?
MR. YAMADA: Yes.
MS. ISAACS: Al is with Fresh Produce
Association of the Americas.
224
And you are here representing James Cathey
with Produce Kountry.
MR. YAMADA: Yes. Thank you.
My name is Al Yamada. I'm here because Jim
Cathey, who is a grower, packer, and distributor
and has operations in Tennessee, California, and
Arizona, couldn't be here, and he wanted a short
statement read for the record, so I agreed to do
that. So allow me to make it as short as
possible considering the hour.
I'm afraid that much of this current rush to
create an all encompassing voluntary guidance for
fruits and vegetables is ruined by an irrational
desire to accomplish the unwarranted.
Facts do not support the need to focus on
imports as a source of food-borne illnesses.
Looking, however, at the way the President's
announced initiative to ensure the safety of
imported and domestic fruits and vegetables, one
would also assume that if there were no imports,
there would be no food-borne illnesses and no
more outbreaks. Many would say that it's wrong,
but I'm afraid, again, that just as many probably
would be happy to let the public reach that wrong
assumption.
225
As a businessman with domestic and
international experience, I believe a proposed
guidance will affect more American farmers than
foreign farmers. The reason is that foreign
growers are already used to rigid inspections and
they're prepared to meet whatever standards
established here. Since all imports come through
check points or better known as ports of entry,
they are already subject to these sort of
inspections. Foreign farmers are more likely to
be ready, therefore, to meet the challenges
proposed by the proposed guidelines.
Meeting budgetary standards is simply one of
the costs of doing business, but is the cost
warranted in this extended cost effective. The
answers are not very clear.
While foreign producers might take the
position that they need to do whatever's
necessary to carry on trade, domestic growers
think the guidance is unnecessarily onerous.
I would like to discuss two points briefly;
one is that of international trading standards,
the other is domestic growers.
In Tennessee this past summer, some of the
local growers, including growers in Virginia and
226
the Carolinas, were delivering tomatoes to me in
used cartons, and I observed even tree fruit
packed in used tomato boxes, and when I pointed
out that reusing cartons is illegal, a Virginia
agricultural official told me that no one had
ever mentioned that to him before, and he also
didn't want to discuss how they enforce that type
of law there.
In contrast, if any American importer were
to deliver to any port of entry produce in used
boxes, that product would be turned back and the
shipper would be in big trouble.
Simply put, imports automatically meet
federal standards or they do not get into the
market; they do not come into this country. The
same is not true with all domestic produce,
because they do not necessarily go through an FDA
checkpoint.
The other point is about international
trading standards. I said earlier that foreign
shippers probably will do whatever is necessary
to meet U.S. standards because they want to trade
with Americans. Of course, Americans want for
their fruits and vegetables to complement the
domestic supply.
227
That does not mean that foreign shippers
will tolerate any standards. At some point, they
are going to object or they are going to insist
on similar standards on U.S. agricultural
products that go into their country, then we will
all know how much trouble can be caused by these
proposed guidelines.
That is why this most important proposed
guidelines be done non-discriminatory towards
foreign agricultural products, and that the
guidelines be in conformity or in line with
proposed international trade agreements.
The proposed guidelines must not become, not
be perceived as non-tariff trade barriers.
American agricultural exporters, including the
Florida Citrus Growers, have experienced exotic
regulations overseas. They realize that the
regulatory game can be played in many ways by
different countries.
Furthermore, American trade negotiators have
constantly fought against discriminatory
regulations overseas. FDA, therefore, should
more firmly take into consideration the
possibilities of international trade
repercussions before finalizing the proposed
228
guidelines.
My final point is to question the need for
this moniminiacle dash to the finish line. The
whole effort is moving at a speed that is totally
uncomprehensible and unsupported by science or
data. Raising public awareness of safe food
handling practices has always been (inaudible)
but the public must understand that the farm is
not where all the problems start, and the FDA
should not focus it's safe initiative on only
farming operations.
Thank you.
MS. ISAACS: Thank you, Mr. Yamada.
MR. YAMADA: Thank you.
MS. ISAACS: Do we have any additional
industry presenters at this time?
(No response.)
MS. ISAACS: Okay. As we mentioned, if you
have additional comments, be sure to send in your
written comments after the meeting.
Okay. On the other stakeholders' side of
it, we have Rebecca Schleifer? Schleifer?
MS. SCHLEIFER: Schleifer.
MS. ISAACS: Schleifer.
MS. SCHLEIFER: Yes.
229
MS. ISAACS: And Rebecca is an attorney and
has a master's in public health, and she works
with the Migrant Farmworker Justice Project out
of Belle Glade, Florida.
MS. SCHLEIFER: Ms. Isaacs, my name is
Rebecca Schleifer, I'm a staff attorney with the
Migrant Farmworkers Justice Project in Belle
Glade. I also have a master's degree in public
health and I do a fair amount of public health
education both with Florida advocates and also
some with health care providers.
I just have three brief remarks, and one
comment on something that was -- something that
came up this morning.
I think we probably all agree that field
sanitation facilities in the fields are
important. I just wanted to comment that, first
of all, the best information that we have on a
national basis, which is the National
Agricultural Worker Survey, or the NAWS Survey,
reports that only one-third of farm workers have
adequate drinking water, water for washing and/or
toilets in the field.
My own experience working both here in
Florida and Washington State, supports the fact
230
that, in many fields, farm workers don't have
adequate access to toilet facilities, and even
where there are toilet facilities, often they are
not clean or they lack doors, or there are enough
of them.
Also, the federal standards require that
field sanitation facilities be present if there
are 11 or more farm workers in the field. We're
fortunate in this state that the state law also
required that if there are five or more farm
workers, that such facilities be present.
I just wanted to say it would be great if we
could be like the four states that require these
facilities if there are any farm workers present
in the field, and those are other states which
have a significant population of farm workers;
North Carolina, Washington, Oregon, and
California.
My third comment is just one other problem
that we hear a lot about from farmers with whom
we work is that even, again, when there are
facilities present, they often aren't given time
to use them. This is particularly a problem
for -- or we hear this is often a problem for
people that work in packing houses where people
231
work in a line and they all have to -- they can't
just leave when they want to.
Oftentimes, people are given ten minutes and
there's 30 people in the line and there's often
not enough time to go. So this is something that
people should pay attention to to make sure that
people are using facilities and using them
properly.
My only final comment is that I think that
it's good that the guidance does talk about the
importance of workers reporting their illnesses,
and also of accommodating workers with illnesses
or diarrhea or lesions. I just think that people
should be realistic about this kind of
expectation in a climate where workers are very
fearful of reporting any kind of problem for fear
of being fired or otherwise retaliated against.
MS. ISAACS: Thank you.
Okay. Who's business card did I lose? Who
else wanted to present?
Yes, sir. We'll let you introduce yourself.
I'm sorry about that. Dr. Malecki has your card.
MR. PAIGE: Here, you can have one.
MS. ISAACS: Well, then let me introduce
you.
232
MR. PAIGE: Oh, okay.
MS. ISAACS: All right. This is Stephen
Paige. He's the director of the Bureau of
Environmental Health Services, and you're from
Topeka, Kansas, Department of Health and
Environment.
Thank you for joining us.
MR. PAIGE: Thank you. And why am I here?
Well, I understand that the forecast low at home
is 14 degrees; that's why I'm here. I may stay
all month.
There's a couple issues I'd like to talk
about. I apologize for not having prepared
remarks as I just read the document this morning.
First of all, I think the issues related to
water should be left alone. Water is regulated
to death, and it just seems to me that another
comment or two about regulation of water would
just cause problems in our 50 states and 5,000
local agencies that deal with water issues from
ground water to surface water to agricultural
irrigation water, and I think that if the
guidance document refers to water, they ought to
just say, shall comply with any local -- state or
local ordinances or requirements regarding water.
233
If we do more than that, I'm afraid we'll run
into conflicts.
For example, suggesting one water sample per
year from an otherwise properly constructed and
located well, is probably in contrary with some
local standard someplace. And unless the FDA
wants to drop their preemption of local codes and
ordinances, I think that would run into a
problem.
My next comment would be in regard to
sprouts. I see no other place in the documents
that we have to regulate or control sprouts in
regard with causing food-borne illnesses.
Sprouts are not well organized. Sprouts
would be, I would say, a fledgling industry, done
from small -- small shops; one, two, three people
shops, that have sprouteries down to sprouts that
are grown by the restaurants in the hand sink or
whatever.
The issue is that sprouts have a real
potential for causing food-borne illness. I
speak from experience. This year, we had an
outbreak in the Kansas City area of Salmonellas
associated with sprouts grown by one company in
Kansas City, Kansas.
234
We had 105 cases of Salmonella infantis. We
didn't have any deaths, and we didn't have any
bodies from that, but we had, I believe,
52 percent of the cases had bloody diarrhea and
thought they were going to die.
The cost of that was tens of thousands of
dollars, tens of thousands of dollars for the
consumer, 105 people with Salmonella infantis;
that is a phenomenal expense to them both in
wages lost and medical treatment, including
hospitalization. The cost to my agency was tens
of thousands of dollars. The outbreak started in
February. Geez, the final report was probably
written in August. Our last case was sometime in
April.
The cost there was phenomenal. Let alone
the time it took away from our other business.
The cost to the industry of this particular
outbreak wasn't a whole lot, it was just one
business, a three-person staff; one owner and two
part-time helpers out of business for good.
There will be no more sprouts sold under that
name.
The cause of this outbreak was contaminated
seed. There have been other outbreaks in the
235
country; it's an international problem. There
have been outbreaks in Canada and Japan. The
outbreaks associated with sprouts have been so
far restricted to Salmonellas and E. Coli 015787.
And as you know, the significance of infections
and disease caused by E. Coli 015787 is more than
just the entire disease. The causes, the
lifelong problems caused in children from
disinfection is devastating.
The problem being contaminated seeds is not
going to go away. Alfalfa sprout seeds are
raised -- are grown and harvested with the
intention of raising more alfalfa plants.
Generally, alfalfa plants are used to feed
cattle. Grown in fields, it's harvested with
combine, it's baled, it's stored, and we feed
cattle.
However, if the restaurateur or the person
that runs the small sproutery decides that he
needs more seed, he goes to the feed and seed
store and buys a small quantity -- a relatively
small quantity of alfalfa seed to raise his
sprouts.
So those seeds that have been combined off
the ground from the alfalfa field where the
236
combine could have hooked to the ground and
picked up some dirt, combine could have picked up
a snake as far as that goes or reptile or other
contamination from animals.
I have a picture of an alfalfa field that
was cut to harvest the seed and, in the
background, there's a cattle feed lot. So what's
the likelihood of something that's on the ground
going from the ground to an incubator, being the
sprouter, to our salad, being contaminated. The
likelihood is great.
I think at this time, we need to have some
direction from FDA or USDA or both from the
university that would provide us some guidance as
to how we can help industry obtain or use or
somehow provide safe seed for producing alfalfa
sprouts.
The likelihood of producing a seed from the
field that isn't contaminated is not realistic
and I don't expect that to ever happen. We need
to have a critical control point at the
manufacturer's level that will prevent
contaminated seed from getting to the consumer.
More than likely, there are in the
neighborhood of 200,000 salad bars in the United
237
States. That's just my guess. If anybody wants
to refute that, that's fine. But let's say there
are 200,000 salad bars in the United States.
Most of those have sprouts as one of the items to
be selected off that salad bar.
A lot of people that eat sprouts don't know
they eat sprouts. When we did our epidemiology
on our outbreak, it pointed to lettuce as being
the causative food of the outbreak.
Well, it was more or less a -- a hunch that
we sampled some sprouts. Most people -- or a lot
of people did not realize they had eaten sprouts
when they had eaten their salad or their
sandwich. Sprouts were an unknown ingredient in
those products that were eaten.
With our hunch, we found that we had
Salmonella infantis isolated from the stools of
the sick people, we had Salmonella infantis
isolated from sprouts from the sproutery, from
the seed, from the seed producer, and from the
equipment in the facility that produces sprouts.
So there's no question in this case that the
cause of morbidity was contaminated sprouts, and
the cause of that was contaminated seed.
So I would urge FDA to give us some tools so
238
we can help industry provide them clean sprout
seeds.
Thank you.
MS. ISAACS: Anyone else?
Yes. Go ahead, Stacey.
DR. ZAWEL: Stacey Zawel with United. I
just wanted to make two brief comments for the
record.
One of them, Dr. Malecki gave a very good
presentation of the raspberry and cyclospora
outbreak in this area. I thought that was very,
very good.
And one of the things that I'd like to point
out is the example that it sets that, in fact,
FDA and CDC have been down in Guatemala for two
seasons now, trying to help out the Guatemalans
and address this issue, test different -- test
the product for cyclospora, test for water
sources and other, and they haven't been able to
find it.
I think it provides a very good example for
the fact that we don't have enough science to
understand what our interventions are actually
achieving, so we need to be careful.
The second thing is something that I, as an
239
industry representative of many different
commodities, have to say over and over and over,
and I really can't emphasize it enough, and I
know sometimes I sound like a broken record, but
when we talk about all these outbreaks, we have
to really be very, very careful to talk about the
vehicle that was associated with contamination
and not speculate as to where that might have
happened.
Especially in instances of today, I'm
specifically stating this for the media that is
in our presence. I think all of us need to be
very conscious of the statements that we make,
and so while we understand, and I certainly
understand, nobody intends to wrongly implicate
something. It does have a huge economic impact
on, perhaps, an innocent industry, and so I just
want to clarify that the strawberry and hepatitis
outbreak was a frozen strawberry outbreak that
was a vehicle contamination and, in fact, the
strawberries were grown in Mexico, were processed
in California in the frozen state, and that is
what contaminated people. We just don't know
where the contamination, in fact, occurred in
that outbreak.
240
MS. ISAACS: Okay. Thank you, Stacey.
Anyone else?
DR. ISMAIL: This is Mohammed Ismail with
the Florida Department of Citrus.
We do acknowledge the -- definitely, the
sincerity of the Food and Drug Administration and
the President's Initiative. And the guidance
that have been developed so far are excellent and
could serve as a guideline for each of the food
and vegetable industries throughout the United
States as a starting point to develop their own
voluntary guidelines that would suit their own
industries.
And in the meantime, some of the funding
that is -- and the dollars that are being spent
in this effort should be going into research, and
each of the land grant colleges, universities, as
well as USDA scientists, should be given adequate
funding to really look into the scientific
vehicles or scientific merits of various problems
and develop the data that is needed to make this
process truly science driven.
MS. ISAACS: Thank you, Dr. Ismail. Right?
DR. ISMAIL: Yes.
MS. ISAACS: I'm getting good at that.
241
Anybody else? Come on down.
MS. GOULD: My name is Lauren Gould. I'm
from the Miami, Fort Lauderdale area. I'm a
member if Florida Certified Organic Growers and
Consumers. I'm also an extremely pesticide
sensitive person due to working in a nursery over
25 years ago where I received my lifetime supply
of drift.
My feeling from a consumer standpoint is, if
safety is truly at the crux of this matter, why,
besides the almighty dollar are certain
pesticides still produced? Specifically DDT and
Temik?
And we know for a fact that there are
countries all over the world who still use DDT,
and that consumers unknowingly, unwittingly or
whatever, then eat products which have the DDT in
them.
So what I really would hope would occur is
for there to be a list of all the countries that
use these really detrimental, highly toxic
pesticides to be available to the general public
so the public can make a truly informed choice.
See this list, see which countries are on it, and
then decide if they want to buy that product.
242
Further, I was really quite stunned to see,
in a trade journal about a week or so ago from
another country, that Temik -- which, for those
who may be not familiar with it, it's a granular
pesticide that, if a bird touches it, the bird
actually cannot fly away because it will die;
it's that potent. I forget what the LD-50 is on
it; it's something extraordinary.
But also, I would hope that somehow we can
look at some alternative safe ways to combat some
problems that exist.
For instance, Medfly. That, not just the
wholesale spraying of malathion, perhaps
something like Neem, which has an LD-50 of zero
because you can literally spray something with
Neem, and then eat the fruit or the vegetable.
Neem is, for those of you who are aware of
that, it's -- what Neem is to India what petrie
oil is to Australia. It has widespread uses.
There are Neem conferences held all over the
world at various times of year.
Anyway, so that's an opportunity that I
think we're missing. And, also, the adequate
removal of the dropped fruit, which is perhaps a
root cause of some of this.
243
And I think immediately of so many starving
people. Why not contact somebody like Second
Harvest, or some of these other gleaning groups,
so that for the grove owners that think that it's
not feasible financially for them to go out and
pick the fruit either from the trees or from the
ground, now maybe they have what will actually
work as a tax benefit to them.
There is also, as far as nutrition goes, in
terms of organics -- I'm not really here to talk
about organics -- but there was a study done at
Rutgers University, which I'll be happy to give
for the record.
Also, I'm really concerned about adequate
labeling. And that concern is based in when I,
as a consumer, go somewhere to purchase some sort
of pesticide and I see inert ingredients. And it
says, inert ingredients, 97 percent. What are
those inerts?
Because I've heard tell that there's some
not too pleasant things in the inerts. So I
really hope that the people who are pushing for
inert -- well, thorough labeling can play a force
in this as well.
Thank you very much.
244
MS. ISAACS: Okay. Thank you. Do you have
written testimony to leave?
MS. GOULD: No, but I will be happy to
provide it.
MS. ISAACS: Thank you very much.
Okay. Richard and Terry, you wanted to say
a few words?
MR. BARNES: Anybody else that has any
comments? Have we -- okay. Dr. Vanderveen?
My comments, I just would like to, finally,
to thank all of you.
Your input is very important to us, your
testimony here, and also written input, as Terry
said and as Lynn said, we have until December and
probably after that to get it to us.
We want to hear from you; we want you to
stay involved. As I told several people earlier
today, we want you to be a part of this process.
That's the reason for these meetings, that's the
reason that we are going down this road, that's
the reason it's guidance. We want you to be a
member of the food safety team, and although most
of you already are, but we want to keep you
involved and make sure that we have a chance to
keep you involved in it.
245
So please do provide us with your input, do
provide us with your comments. We need that.
Terry?
DR. TROXELL: Well, yes. I wanted to second
everything Richard has said, that we very much
appreciate that you came out and provided these
comments, a lot of good comments, and we'll be
taking all of them into consideration.
I did want to take one minute to talk about
the rush. Yes, it has been, at least for me,
kind of a rush to get ready for public meeting
and these town hall meetings.
However, the first priority for us is
getting it right, and you can be assured that
we're not going to rush it out if it's not right.
So we're going to be taking all the time we
need, have additional comment documents available
all along the way as necessary until we can get
this right.
Thank you.
MR. VANDERVEEN: I would just like to say we
heard you, we'll pay attention to your comments.
It will take us quite a while to digest them, and
we'll be back, and hope that you will continue in
this process, because it's absolutely critical,
246
we hear that it's critical, and we want you to be
aware of them.
And we will -- at each step of the way,
whatever happens, we will try to make you aware
at a time when you can get back to us.
Thank you.
MS. ISAACS: And thank you for coming down
to Florida.
And I would like to remind the folks who are
still here, if you didn't sign in on the
attendance sheet, please do so. There may be
some follow-up mailings or something, or extra
credit points or something, I don't know. I
don't know. I'm just kidding, you know. So be
sure so sign up so we've got a record of who
participated.
And thank you so much for your active
participation today. I didn't attend the other
two meetings, but I'll bet you ours was the most
interesting so far.
So thanks a lot. Send in your written
comments, if you've got some, and many, many
thanks to Clayton Hutcheson for his hospitality
of him and his staff, and Audrey Norman
(phonetic).
247
And for those of you -- I know we were going
to wrap up at 4:00 o'clock -- for those of you
who would like to stick around and see the
15-minute video -- is that right, Gary?
MR. SMIGLE: Twelve.
MS. ISAACS: (Continuing) Twelve-minute
video that Gary brought.
What is it about, Gary?
MR. SMIGLE: It's about the growing
practices used in Mexico versus the United
States.
MS. ISAACS: Okay. So you're welcome to do
so. We will put that on now.
And thank you again.
(Thereupon at 4:15 p.m., the public hearing
was concluded.)
- - -
248
C E R T I F I C A T E
THE STATE OF FLORIDA, )
COUNTY OF PALM BEACH. )
I, Toni M. Salopek, Registered Professional
Reporter, State of Florida at large, do hereby certify
that I was authorized to and did report the above
public hearing at the time and place herein stated,
and that it is a true and correct transcription of my
stenotype notes taken during said public hearing.
I further certify that I am not attorney or
counsel of any of the parties, nor am I a relative or
employee of any attorney or counsel of party connected
with the action, nor am I financially interested in
the action.
The foregoing certification of this
transcript does not apply to any reproduction of the
same by any means unless under the direct control
and/or direction of the certifying reporter.
IN WITNESS WHEREOF, I have hereunto set my
hand this 12th day of December, 1997.
__________________________
Toni M. Salopek, Notary Public
in and for the State of Florida
My Commission Expires 12/30/99
My Commission #CC 510695
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