U. S. Food and Drug Administration
U. S. Department of Agriculture
December 3, 1997
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_____________________________________________
FDA/USDA TOWN MEETING ON MICROBIAL RISKS
FOR FRESH PRODUCE
_____________________________________________
HELD ON: December 3, 1997
HELD AT: Cornell University, Jordan Hall,
Geneva, New York
BEFORE:
RICHARD BALDWIN: Acting regional director of food
inspection services, New York State Department of
Agriculture and Markets
MARK MCLELLAN: Cornell University
MARVIN PRITTS: Cornell University
JOYCE SALZMAN: Center for Food Safety and Applied
Nutrition
THOMAS GARDINE: Center for Food Safety and Applied
Nutrition
REPORTED BY:
MICHAEL D. MINNIES
Shorthand Reporter
Notary public
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BEVERLY KENT: My name is Beverly
Kent and I am with the Buffalo office of the Food
and Drug administration.
Just a few administrative details:
The restrooms are located on the
bottom floor. Keep making a right turn until you
no longer can.
For lunch, if you turn right out of
the parking lot and left at the first light there
is a restaurant on the right. Or continue on the
road and at the second light, make a left and
there will be a number of fast food restaurants.
You should have in your package two
documents, the guidance document and the Federal
Register Notice dated November 28, 1997. There is
some information in the Federal Register Notice I
would like to mention. The written comment period
ends December 17. Please be sure to list the
docket number on your comment. The docket number
can be found in the Federal Register. A list of
the town meetings is also in this document, and
how to request a transcript of the meeting, can
also be found in this notice.
I would now like to go over the
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agenda. If you would turn to the second page, at
1:30 there will be industry group presentations.
If you are with an industry group and wish to give
a presentation, please let me know at break.
Now, I am going to have the panel introduce
themselves.
RICHARD BALDWIN: Richard Baldwin,
Acting Regional Director, Northeast Region, Food
and Drug Administration.
JOE FERRARA: Joe Ferrara, Director,
Division of Food Inspection Services, New York
State Department of Agriculture and Markets.
MARK MCLELLAN: Mark McClellan,
Cornell University. Welcome to Geneva, New York.
MARVIN PITTS: Marvin Pitts, Cornell
University.
JOYCE SALZMAN: Joyce Salzman,
Center for Food Safety and Applied Nutrition.
TOM GARDINE: Tom Gardine, Center
for Food Safety and Applied Nutrition.
BEVERLY KENT: There are two more
people, at least two more, who were actively
involved in arranging the grassroots meeting. They
are Camille Brewer from the Food and Drug
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Administration and Tom Willis from the United
States Department of Agriculture.
Richard Baldwin, Acting Director,
Northeast Region of the Food and Drug
Administration will begin by extending a welcome
on behalf of the Food and Drug Administration.
RICHARD BALDWIN: On behalf of the
Food and Drug Administration, I'd like to welcome
you to this grassroots or town meeting.
I'd like to emphasize a few points
about the President's Initiative. First of all,
it is collaborative. It includes the US
Department of Agriculture, State and Local
Departments of Agriculture, and it includes you.
This is a second in a series of
meetings held throughout the country to insure
that the concerns of the public are considered in
this initiative. Town meetings are rooted in
history of this country. Their purpose is
interwoven with the very principles of democracy.
In the town meeting forum, all parties have a
right to speak, to air issues and concerns in an
atmosphere of openness.
FDA, particularly the Office of
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Regulatory Affairs, has sponsored in the last few
years over sixty town hall or grassroots meetings
on a variety of topics related to FDA's mission of
consumer protection. Today, I encourage you to
listen very carefully and speak frankly and
candidly on the topic at hand.
First, I would like to tell you a
little about the FDA. Then I would like to speak
more specifically about the role of FDA in this
initiative. FDA monitors domestic production of
imports, transport, storage and sale of $570
billion worth of products annually. The Northeast
Region encompasses the states of New York,
Vermont, New Hampshire, Maine, Massachusetts,
Connecticut, and Rhode Island. The NER is also
one of the major import areas in the United States
particularly along the Canadian border and the New
York City area.
Among other things, it is FDA's
responsibility to see that foods on American
tables is safe and wholesome. Part of our role is
to try to prevent problems before they occur.
Assessing risks is at the core of the FDA's public
health protection duties.
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Based on our public health
responsibilities, the President 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,
not regulation. 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 is essential that you
understand that not new regulations are planned on
the microbial safety of food in the immediate
future. Tom will address the issue of regulation
more specifically in his presentation.
The task at hand is two-fold.
First, we plan to review some of the major
features of President Clinton's Initiative on
Fresh Produce. Tom will give you a background of
the initiative and the forces that led to it.
Secondly, and most importantly, we
need your input into the draft guidance on Good
Agricultural Practices. The draft that is in your
information packet is just that, a draft. It
represents our first stab at this issue. It
reflects the preliminary thinking of the FDA and
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USDA. The Produce Subcommittee on Microbiological
Criteria in Foods, and advisory body to FDA has
reviewed this draft. Their comments have been
incorporated. Now, it is your turn to take a
crack at it; to review it critically and provide
your input. Comments from all over the country
will be considered and incorporated, as
appropriate in the final draft that will be
published sometime early in 1998 in the Federal
Register, a government publication. You get
another opportunity to provide comments after
publication of that draft. Then the official
guidance document will be published in the Federal
Register. It will also be posted, as will the
draft, on the FDA web site. The Address of the
web site is included in your information packet.
I don't want to steal Tom's thunder,
so I will turn the podium back over to Ms. Kent.
We are looking forward to a lively discussion with
you later today.
(The Following are outlines of Mr.
Ferrara's opening statements:)
MR. FERRARA: Welcome on behalf of
the New York State Department of Agriculture and
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Markets.
Brief overview of Division of Food
Safety and Inspection and some insight into our
role in protecting the food supply.
Staff - approximately 185 permanent,
plus seasonals, harvest season.
Two primary areas of responsibility:
Food safety and labeling; farm product grading and
inspection.
Produce and egg branding law
enforcement.
Focus on food safety - approximately
100 inspectors and supervisors, (field staff.)
Jurisdiction - 28,000 food handling
establishments. Stores, food processors,
warehouses, etc.
28,000 inspections.
Approximately 6,300 - samples for
chemical or microbiological analysis.
Approximately 2,050 - samples of
fresh produce for pesticide residue.
Contract USDA - pesticide data
program, 1 of 9 states. Pesticide residues in
fresh produce not a significant problem. Micro
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quality more significant.
Contract USDA - custom
slaughterhouse inspections.
Contracts of partnerships - FDA.
Domestic food samples. (Produce).
Imported food samples.
Market basket sampling - pesticides
and Mycotoxin analysis.
Inspections for FDA.
Participate in foodborne illness
investigations with Health Department
Epidemiologists - CDC, FDA, USDA.
Handle tracebacks, foods implicated
foodborne illness - particularly on produce. And
One of the issues which needs to be addressed at
this meeting: Mixed lots, limited records, no
codes, short shelf life.
Investigate numerous product recalls
and seizures each year. Adulterated and
misbranded. Two of the largest this year involved
hummus, histerin, ginsing drinks, alcohol.
It has become clear that
agricultural practices can have a significant
impact on the safety of our food supply. We need
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to look at: Water quality and use; manure and
sewage sludge; worker hygiene, sanitation and
health; and transportation, etc.
It is clear that the good reputation
of fresh fruits and vegetables is at stake.
Rare day that we don't get some
inquiry from the news media regarding food safety
and increasingly that inquiry pertains to fresh
produce. Both familiar pathogens and emerging new
pathogens are turning up in products previously
considered to be safe.
You are all familiar with the recent
fresh produce related problems:
Listeria monocytogenes - e.coli
0157H7 - lettuce;
Hepatitis A - strawberries;.
Cyclosprora - raspberries;.
Salmonella - melons, cut melons, now
potentially hazardous food requiring
refrigeration;.
E.coli 0157:H7, Salmonella and
Cryptosporidium - fresh cider;.
Botulism - shredded cabbage, circus
workers.
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First state to develop reduced o2
packaging guidelines for fresh produce and other
foods.
Scientists recognized potential
botulism hazard associated with pillow pack type
produce packages and other foods in reduced 0
degree packaging (salad mixes).
o2 reduced via vacuum, gas flushing
(co2 and nitrogen) - natural respiration of
produce - use o2 and replace with co2.
Improves shelf life by controlling
spoilage aerobes and reducing oxidation.
Enhances environment for anaerobes
such as clostridium, botulinium and listeria
monocytogens, some of which will grow at
refrigeration temperatures.
Signs of off condition usually
relied on by consumers missing - odor, sliminess,
discoloration.
Temperature control.
Minimum o2 level - gas permeable
container - match respiration rate of produce - 21
percent - 1 percent.
Variable type produce - shredded
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lettuce versus leaf.
Product temperature - higher rate of
gas transfer through film.
Competing harmless microbes.
Many of these outbreaks seem to be
related to the way these products were grown or
harvested.
The development of Federal "Good
Agricultural Practices" guidelines is certainly a
welcome first step in addressing this problem.
We certainly support the use of
grassroots meetings such as this to get the vital
U.S. Producer input necessary to make these
guidelines both relevant, user friendly and
effective.
Welcome once again and I hope this
is a productive meeting for you. Thank you.
MARK MCLELLAN: My name is Mark
McLellan. I am director of the Cornell Institute
of Food Science and chairman of the Department of
Food Science & Technology here at the NYS
agricultural Experimentation in Geneva.
We appreciate the opportunity to
host this meeting in Geneva. The Geneva
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Experiment Station is a division of the College of
Agriculture and Life Sciences at Cornell
University and has a long history of supporting
research and outreach to the fruit and vegetable
industries. As faculty members of the Cornell
Institute of Food Science we have many key
resources focusing on the issues of food safety.
We have specialists in the areas of: Food
spoilage, foodbourn human pathogens, outreach and
communications, risk communication, bioanalytical
detection methods, rapid screen methods as well as
commodity based food safety specialists. Food
safety is an increasingly important issue to
consumer; they are awakening to the reality that
the real risk in our food supply is foodbourn
disease. Many, for the first time, understand
the overwhelming data showing an almost
nonexistent risk due to pesticide residue in our
food supply and the very real scientific evidence
identifying significant risks due to foodbourn
disease. The facts are that foodbourn disease
accounts for 9000 deaths per year, based on
conservative estimates. The total dollars lost
due to uncollected wages, lost productivity, and
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related health care costs is well into billions of
dollars per year. This is no small matter nor
should the associated risks due to foodbourn
disease be trivialized.
Having said this, it is important to
remember that we are fortunate to have a food
system in the US that, on a relative basis, is one
of the very safety in the world. In particular
our system of growing and retailing fresh and
minimally processed fruit and vegetable products
is the envy of the world. Still, the numbers
confirm that we are experiencing a significant
amount of foodbourn disease, a part of which is
due to fresh fruits and vegetable. Epidemiology
results also confirm that outbreaks attributed to
fresh fruits and vegetables are increasing over
the last few decades. We need to address this
increase, but we need to use a common sense
approach based on sound science.
After reading the draft FDA/USDA
document carefully, I am convinced that it is on
the right track. With some specific
modifications, this document will help focus
production agriculture and the associated fresh
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and minimal processing industries on the key
issues which impact the food safety of fresh
produce.
Again let me welcome you today and
invite you to visit the departments and facilities
of the Geneva Experiment Station and in particular
the department of Food Science and Technology.
BEVERLY KENT: I do have a list of
some of the industry groups that would like to
give presentations this afternoon. If anyone else
or any industry group is interested, please see me
during lunch and I can set up the presentation.
You each will be allocated about 15
minutes.
THOMAS GARDINE: Okay. Now some of
the details on the guide to minimize microbial
food safety for fresh fruits and vegetables. Two
words to remember, guide and second, minimize.
And I guess a third phrase, microbial food safety
hazards. It is not all inclusive, it is focused.
It is a guidance, it is not a regulation, and we
realize the best we can do is minimize this hazard
given the fact that God's earth and God's sky is
not sterile earth and sky.
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What you heard recently about
outbreaks have raised concerns about the safety of
foods, including fresh fruits and vegetables that
are not processed to eliminate pathogens. What is
the concern here is not a case where frequently
the produce that we are talking about here is
going to get a chance to be cooked either in a
processing facility or in the consumer's home,
this is something people eat as in the form that
they take it home, from either the farm store or
the supermarket. There is no additional
protective steps, so all the protection has to
come from care at the grower level.
As you heard, they are not subject
to many of the steps designed to reduce, eliminate
microbes that processed foods receive, because
they are not processed foods. Therefore, it is
your responsibility to take steps to reduce the
risk of microbial contamination. It is
particularly important for raw produce.
A guideline of your document, the
draft guideline is right up here. Working
together with USDA and some of the source
documents that we have available from industry, we
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focused on what are the areas that are
controllable on the part of a grower that might be
introducing microbial risks to fresh produce. We
came up with four general areas that you will see
exactly the way the draft guidance a set up:
water, manure worker, field and facility
sanitation, hygiene and transportation. Those are
the key areas. That is what we are going to be
talking about today.
Maybe you hadn't heard me say this
already, but the guide is intended as guidance
only, it is not a regulation. It does not compose
mandatory requirements on industry. We urge
growers to take a proactive role in minimizing
food safety risks. And we know growers have been
doing this.
As I said before, the industry was
in front of the curve on this. The industry was
already responding to a problem, why, because the
industry saw it as a problem, not only public
health wise, but in the terms of the acceptance, I
would think, of your product with the American
consumer.
The document is broad in scope, it
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is intended to be applicable to most produce, so
we are focusing on common elements in growing
production and distribution design to reduce the
risk of microbial contamination.
We realize that there are many, this
is very important, we know there are many gaps in
this science that lead to inserts in the degree of
risk associated with particular farming
practices. Hell, if any of us, if you as growers
or we as regulators knew a specific thing that was
doable that would solve this problem, it wouldn't
be guidance, you would want to do it, and we would
be telling you to do it, if it was not the sort of
thing that would break the bank.
There are gaps in the science, and
when there is uncertainty that is why in the
document we point out where there is uncertainty
in the science, and we will frequently say things
like where feasible, where feasible. This a
document that I'm quite confident both industry
and the involved federal agency will want to
revisit in five or six years or perhaps sooner as
the science gets better, and maybe get the
guidance in it better. It is intended to, for
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identification, practical advice proper qualified
when the science is unclear we try to make that
clear in the document.
And as another part of the
President's Initiative, USDA and FDA have been
charged to accelerate research in an attempt to
eliminate some of these gaps.
In some areas guidance may properly
be more specific, such as when practices are
subject to federal, state or local laws. This
goes back to a comment we heard from the floor,
there are local requirements, there may be state
requirements, and in some cases when you start
talking about packaging and processing, minimal
processes, such as cutting and packaging, there
are local, state and federal laws and
regulations. Nothing in this guidance will say
you could ignore current existing local, state or
federal requirements. And as was pointed out, the
FDA "good manufacturing practices" which would be
very applicable to packing houses is contained in
21 code federal regulation part 1K.
Why we think the broad scope GAP
G-A-P is worthwhile, is because we do believe that
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there are common potential vectors for pathogens
for all fresh produce, such as water and manure,
which we will be talking about. We also realize
there is an enormous range of difference in water
available to specific growers and farm size in
general, climatic and soil conditions and in the
resources available to a grower. That is why I
was very intrigued when someone at the Grand
Rapids meeting referred to this as almost a
self-assessment program that growers could use
based on the knowledge and science contained in
this document.
But we do realize that this is not a
one-size-fits-all and we encourage growers to take
it and apply it as best as feasible to their own
operation and the limits that the reality of their
operation imposes on them.
And we already covered the first
part. Cultural practices will differ around the
country, but the second bullet there is what you
are here to help us answer. This is what we want
your comments from the floor or in writing how can
we best provide practical advice to growers that
will move us to safer produce without being
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unnecessarily costly to growers.
As I said, is it a real world
document, we need your help to tell us what is
practicable and what is doable in the real world.
We need your comments as to whether the advice in
this document is indeed worthwhile to publish.
Now, some of the specific statements
in the document, once again, let me repeat the
devil is in the details, and these slides are
going to be a real quick overview. You have got
to read the document and know exactly what is
being said in there. We are not hiding anything
in this set of slides, but details are tough to
get across in the time available to us. So read
the document before you decide you don't want to
comment or you choose not to comment.
The first thing we want to talk
about is water. Water is a concern in two
aspects. Water can be an inherent source of
microbial contamination, and water can be a
mechanism, if improperly used, to spread localized
contamination throughout a packing house or
throughout your harvest. If you don't use the
water properly. Here are a list of some of the
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microbial pathogens that have been found in
water.
The cause of water as a potential,
as a source of pathogenic microorganisms, growers
should carefully analyze practices involving water
with the view to limiting the possibility of
waterborne contamination getting to the produce.
You should recognize as you try to look at your
use of water, recognize the potential for water to
contain pathogens and the water you use should be
of sufficient quality for its intended use.
Now, the quality of the water you
need to use will vary with the use and should be
tailored to the needs of a particular operation.
Let me repeat that. This guidance does not
preempt any applicable federal, state or local
regulations. Growers should consider when you are
thinking about your water usage, identify and
review the source or sources of water used on the
farm and what sources of water you used for what
different operations; a bit of advice that is
contained in the document.
As the degree of water to produce
contact increases, so does the need for better
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quality water. Clearly, if the water is
continuously, especially in the harvest, going to
be placed directly on the crop, you have to be
careful about the water quality. And your review
may include determining whether, of course, the
water is from an open well, canal, reservoir pond,
stream, in determining which of those sources are
appropriate for which needs of water in your
growing operation.
Now, all right, once you do that,
what are your options. Well, among the things
talked about in the guidance, controls may include
a number of options, such as delaying water use,
in quality, improvements, that is kind of hard if
you have only one water use and you have got to
irrigate the crop. We realize that this is an
option given to you if you have this option
available.
Treating the water, alternative
application methods that would avoid, to the
extent possible, water to produce contact, and if
you can afford it, maintain alternative water
supplies. The feasibility of these or other
controls will depend on the intended water use and
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the needs and resources of a particular
operation.
Look, we do realize that if you're a
grower, and your sources of water is the local
river and you have a cattle operation upstream
from you, you don't have many, your options are
limited. You do have some, perhaps you can treat
the water, perhaps, if you could afford it, you
may have alternative mechanisms for irrigating,
depending on what the current water quality is.
These are concepts or ideas contained in the
document.
Irrigation water, many factors
influence a growers' choice of irrigation system,
economics, water availability. Characteristics
and cultural requirements for a particular crop,
depending on the crop grown. You may need to
consider using a water delivery system, such a
drip irrigation that minimizes direct water to
produce contact for certain produce. You should
be aware of the quality of the water used to mix
and load pesticides sprays. You should consider
this a potential source of pathogens. You heard
Stacy, and I think Joe, speak a little bit about
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the cyclosporic raspberry situation in Guatemala.
Let me state from the beginning that the U.S. has
not yet been involved and no vector has been
identified.
But one of the things that people
are considering is on some of the farms in order
to protect their primary well water source from
back flow or contamination from pesticides when
they were doing their crop protection spray, they
would go to the local river and get the water
supply from there and quality from the river water
was not quite as good as quality of well water,
yet it was sprayed on the crop. Something that
they are now thinking very closely about. You
certainly should be.
Another area where water is used is
wash water. Safe and sanitary water is
recommended for use in washing produce in the
field and in the packing environment. Wash water
even with sanitizer may reduce, but not eliminate,
pathogens on the surface of produce, especially in
the pathogens that are internalized, as they can
be with some crops. So just washing your crop is
good, even sanitizer might limit your problem, but
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it doesn't necessarily guarantee you are going to
get rid of all the pathogens. If pathogens are
not removed or inactivated, they can spread, so a
significant quantity of produce is contaminated
instead of sporadic items.
Let's go back to the first slide.
Water is a concern in two ways; one, as an
inherent source of pathogens and, secondly, if not
used properly, if each of your operations are not
designed with thought to eliminating hazards you
might be taking a local, localized contamination
and spreading through everything in a packing
house or everything that you are harvesting that
day. If you are using the same water to wash the
contaminated and noncontaminated products. You
have to think about this, it's one of the
recommendations in the guidance.
The guidance will talk about the use
of chlorine for wash water. I don't know that
there is a need to go into that too much,
something to consider, if it is an option for
you.
Cooling operations. Any time water
in any form can come in contact with a product, it
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is a potential source of contamination. So water
and ice used in cooling should be considered a
potential source of contamination. There have
been outbreaks of illnesses associated with
cooling, and growers should be aware of the water
source used to make ice and follow processes to
reduce the risk of contamination during cooling.
Final point, bottom line, everything
said in the guidance document about water, water
is a vehicle for spreading localized contamination
in addition to being a vehicle for adding
contamination to the product if the water was
contaminated from the beginning.
Next, talk a bit about manure and
sewer sludge. Health officials and scientists
agree that animal manure and human fecal matter
represent a significant source of human
pathogens. Most of the diseases we are talking
about are speed through the fecal/oral route, and
here's the fecal part of that route. The use of
manure or municipal sewage sludge in the
production of produce must be closely managed to
limit the potential for pathogen contamination of
produce. Growers must also be alerted to the
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presence of human or animal fecal matter that may
be unwittingly introduced into the product growing
and handling environment. Just like water, you
have got to think how you are going to be handling
manure, municipal sewer sludge.
Properly treated manure or municipal
sewer sludge can be an effective and safe
fertilizer. Untreated or improperly treated
manure or municipal sewer sludge may contain
pathogens and can contaminate produce. We
recognize that municipal sewage sludge is not
widely used right now, but it has the potential of
perhaps being widely used in the future. That is
why we talk about it in the guidance document, but
the guidance document does talk mainly about
manure, one of the sources of fecal contamination
that might get to your product.
Remember, the diseases, we are
talking about fecal/oral route. One of them is
the use of untreated or improperly treated manure,
nearby composting treatments, runoff or seepage
from nearby livestock or poultry operations,
nearby municipal waste storage or disposal units
and high concentrations of wildlife in growing
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areas. Please remember the last one, I expect a
lot of comments on that. We have been getting
them about the ability of growers to control
animals and what they might leave behind. Please
think about that. We are anxious to hear your
comments on this point.
Growers may need to develop and
follow good agriculture processes for handling
manure to reduce the potential or reducing
microbial hazards to produce. Practices may
include processes such as composting to reduce
possible levels of pathogens in manure. If you
are going to compost or use any of these
processes, you have got to do them right,
minimize, as feasible, direct or indirect manure
to product contact, especially closer to harvest,
such as water, the closer it gets to consumption.
I guess this comes down to that farmer who has got
one source of water and he's downstream from a
cattle farm.
Here are just a list of the
treatments to reduce pathogens. They are
discussed in the document. What we talk about
mainly in the document, however, is composting.
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Composting refers to a managed process in which
organic materials are digested aerobic or
anaerobically by microbial action. Properly
composted manure can be effective and safe
fertilizers and/or soil amendments. Neither we,
nor the USDA, nor your trade organization, have
sufficient data to make specific time and
temperature recommendations that would apply to
all composting, depending on the source of manure
you are using or other manure treatment
operations. Good agriculture practices, based
upon the best knowledge now available, may reduce
the risk of microbial contamination from manure to
fresh produce. What we are saying, if you are
going to compost, speak to your extension agents
get the best advice you can and try to control it
as well as you can.
In the use of untreated manure,
here's another point where we have been receiving
a great deal of comments. Growers may reduce the
risk on contamination from manure untreated, by
maximizing the time between applications and
harvest. Recommended minimums generally range
from 40 to 60 days before harvest. Some
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recommendations are 120 days or longer. This is
something we have been receiving comments on.
Please think about it. We would be very
interested. It is one of the few areas where
specific numbers are given in the guidance
documents. We would be very interested in your
comments on untreated manure.
Natural fertilizers, such as
composted manure may need to be produced in a
manner to reduce the likelihood of introducing
microbial hazards. You have got to compost, as
well you know how. Care should also be taken to
prevent cross-contamination of produce from manure
that is in the process of being composted or
otherwise treated. You have to sort of find a way
to enclose it. Don't put it on top of a hill when
you are growing your produce downhill from it,
where the untreated manure will be carried
downstream in a rain. Likewise improper treatment
or incompletely treated manure may be a source of
contaminatin. Composting and other treatment may
reduce, but might not eliminate pathogens in
manure. Furthermore, it is unknown to what extent
pathogens that survive treatment may regrow in the
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composted product that is stored before use. One
of the uncertainties in the document.
Therefore, to the extent feasible,
the document recommends that some of the things we
suggest for untreated manure, where possible, you
may want to apply for treated manure such as
maximizing the time between application and
harvest. Good agriculture practices for handling
manure may include securing the manure or compost
to prevent cross-contamination from runoff, as I
stated, to present cross-contamination from
leaching into the soil and to prevent
cross-contamination from wide spread.
Sanitation and hygiene, very
important. Anytime you are dealing with food that
people are going to eat, sanitation and hygiene,
particularly of the workers, become critically
important. You don't want to go into a restaurant
where workers don't wash their hands. Let's
remember if this produce is not going to be
processed, the last person to touch it on the farm
should also take the same care with it as with
they would with their own personal hygiene, as you
would expect any food establishment to use. Both
33
health and hygiene play a critical role in
minimizing microbial contamination to fresh
produce. Remember what we are talking about here,
fecal/oral route of disease. Good hygienic
practices by all workers are essential in the
control of microbial hazards, fecal issue
diseases, ill health with diarrhea, open lesions,
and so forth, are sources of microbial
contamination, and can be transmitted from the
hand to the produce.
Personal health of the employees is
very important. We suggest in the document that
employees should be encouraged to report to a
person in charge any information about their
health or activities as they relate to diseases
transmittable through food. Persons in charge
should monitor the health of the employees.
Individuals with diarrheal diseases should not
work with fresh produce. All employees who are
involved in the harvesting, packing and
distribution of fresh produce should be trained in
good hygiene practices.
One of the recommendations in the
guidance advice we give is that the grower,
34
perhaps jointly in a region or through the state
or local governments, should, or extension
service, should consider establishing a training
program for their workers as something as simple a
personal hygiene programs should include a system
to monitor and evaluate compliance. You know you
are making progress with workers.
Washing hands after each absence
from the workstations, using the bathroom, eating,
and before coming to work is very important. You
can't assume people know this. It is a given fact
dirty hands have the potential to gather and
spread germs on the surfaces they contact.
Washing hands with soap and warm water helps stop
the spread of germs. You may have to teach
employees proper hand washing techniques and use
of sanitation facilities, such as onsite latrines,
and avoiding the elimination of waste outside of
these facilities should be encouraged.
As for everything after the end, I
don't know why we didn't say must be encouraged,
but bear that in mind. In the field and a lot of
what we are going to talk about from the field
would also be applicable to the packing house.
35
Toilet facilities, the proximity and accessibility
of facilities for harvest crews in all sectors of
fresh produce products is important. Once again
employees to packing house workers should have
opportunity to use facilities when needed. This
should help the incidence of workers relieving
themselves elsewhere. Make sure that the location
of toilet facilities is not a water source used in
irrigation or in a location that is subject to
potential runoff in heavy rains. Once again, try
to avoid untreated fecal matter getting on your
produce. Facilities should be provided to all
employees. Provide adequate hand washing stations
with water, including warm water, if possible,
that is suitable for hand washing or drying.
Toilet facilities should be well supplied with the
usual supplies, and maintained in a sanitary
condition and in good repair at all times.
Some examples of good operation to
consider, which are in the guidance document,
clean or service portable toilets away from the
field if possible, dispose waste through a
subsurface septic tank system, if possible, drain
waste water away from the field or collect it in a
36
drainage tank to be correctively disposed of at a
remote site. Once again, everything is designed
to prevent untreated fecal matter from getting in
contact with the product and to keep your worker's
hands clean.
Harvesting precautions remove as
much dirt and mud as possible from the produce
while it is still in the field. Cartons are a
source of spreading contamination, and damaged or
muddy cartons should be paired, cleaned or
discarded in an effort to reduce microbial
contamination in fresh produce. You're going to
have a load from the field, there is no sense
adding to it by putting the produce in a dirty
carton. Care is needed to insure that the produce
packaged in the field is not contaminated in the
process. Recommend that inspectors either wash
their hands or wear clean disposable gloves while
inspecting produce.
Equipment, the equipment you use in
the field might be a source of spreading
contamination to produce. So a person should be
in charge of maintaining equipment sanitation and
knowing what equipment should be used for what
37
operation. It may not be wise to have the same
pieces of equipment that was moving manure just an
hour ago now being used to pick up and move some
of your cartons of produce. That would be a
problem. You shouldn't do that. So a person
should be in charge of maintaining equipment
sanitation, keeping them as clean as possible. We
realize in the field environment, in the middle of
harvest, we know you're not going to be
supervising your farm equipment, we are asking you
to do what is feasible and possible, we are saying
keep it as clean as practicable. In a facility,
anything in a process, from harvest to processing
that makes contact with produce, has the potential
to contaminate it, that is the bottling line,
anything that's going to touch the fruit, the
vegetables you have got to think about it, is it
the best you can practicably make it in terms of
microbial safety. Poor sanitation in the packing
house can increase the risk of contamination of
produce and water supplies used with produce.
Once again, to get back to this
other gentleman's comment, there is a lot of
advice in the current "Good Manufacturing
38
Practice" issued by the Food and Drug
Administration, Title 21 of the code of Federal
Regulation 110.20 to 110.93 is a good resource.
Equipment such as knives, saw blades, et cetera,
should be inspected for defects on a regular basis
and replaced as needed. Personnel should not use
equipment that has contact with produce for
carrying other materials such as tools, fuels,
lunches, et cetera. Keep the packing house and
cooling facilities clean and sanitary as
possible.
Pest control, hey, you are in an
enclosed packing house, you have got to worry
about pests. We would expect you to do the same
in that environment as you would with any other
food processing facility, to exclude pests from
the facility. And one of the things here we do
recommend is the use of a pesticide control log,
if it is an enclosed packing house. One of the
few places where a record keeping suggestion is
made anywhere in the document, by the way.
Final route for contaminating
product may be the transportation. Anytime you
handle product before it gets to the consumer may
39
be a problem. Contamination of produce may occur
due to improper practices during handling,
loading, unloading and transportation operations.
Wherever produce is transported the sanitary
condition should be evaluated, especially between
links in the distribution chain. This means
getting it from farm to packing house, from
packing house to market. Cross-contamination, one
of the things you should be concerned about is
cross-contamination from other foods and nonfood
sources, and contaminated surfaces may occur
during transport. Segregate fresh produce from
other food and nonfoods in order to prevent
contamination of the produce. Try to insure that
trucks or other carriers' sanitation requirements
are met before loading produce. What are we
saying there? We are saying don't put your
produce in a dirty truck. Inspect the truck
before you use them, before you put your product
on them. You should keep an open communication
along the transportation chain regarding food
safety risks and the need for adequate safety
steps. You probably should be talking to your
truckers, if you don't own the truck, make sure
40
that people know they are dealing with food, and
it is not just hauling freight.
Onto the guidance document. We have
attached a section that has nothing to do with
control of microbial, minimizing the risk of
microbial pathogens with produce. We attached a
document, a section called, I believe we changed
it since these slides were prepared, positive lot
identification. Getting back to Joe's point, it's
difficult sometimes when responding to an illness,
report that may involve fresh produce to track the
produce to its source.
This document is encouraging
everyone along the chain of distribution to think
about ways to do this. We recommend it for a
number of reasons. Fresh produce will never be
free of contamination, I said this often enough.
We realize it is a nonsterile world. We are here
to work with the grower to do the best job we. It
is never going to be a sterile environment.
Tracebacks don't prevent the hazard. It can limit
the scope of hazards. If the traceback, for
example, if some sort of coding system exists to
enable health officials to trace a problem back to
41
a farm or particular shipper or perhaps a field on
a farm, we do not have to put an advisory out to
the public and say, well, strawberries are a
problem, but we have no idea where they are grown,
which automatically makes all strawberries a
problem.
The better we can focus, the less
risk and less impact it has. It will limit the
population at risk if we can focus on the problem,
we will know where this product is distributed.
And as public health officials, we can do a better
job in removing the product and to advise the
consumer what to be concerned about. It can lead
to the specific company or source or growing field
to the problem, so we can correct the problem. It
will lessen the economic burden on operators not
responsible.
But we realize that traceback,
positive lot identification is something that will
vary, the industry's ability, depending how your
product is marketed, your ability to do this will
vary from crop to crop; but it would be real nice
if you could do as much as you can. We are not
saying that you have to put a sticker on each darn
42
apple or each darn orange, it would be nice if you
could. But we realize that financially might be
totally impractical. Let's identify your shipping
crates. Maybe we should think about making sure
that that is done, that the farmer and everything
is properly identified at least on the shipping
crates and perhaps further if we can.
Traces, a good system for positive
lot identification would minimize the unnecessary
expenditures of public health resources as we try
to run around and find who is responsible for the
problem. Let's remember what I said at the
beginning, fruits and vegetables are good for
people. We believe they are safe. We want to
keep them safe. We want to keep people eating
them. One of the reasons for this initiative is
to insure we are all doing all we can to maintain
public acceptance of this product. We do not want
fresh produce to be subject to the crisis of a
weak environment that might make the American
people question whether it is really good for them
to be eating this product, because, darn, it is
good for them. Operators should examine current
company procedures to trace from farm to
43
receiver. Operators should develop procedures and
technologies to improve traceback from the
receiver to the farm. Once again, this is not
simply the grower, everyone along the distribution
chain we would encourage to think about this. And
to be effective, traceback should have as much
detail as possible. If we had our wish we would
be able to look at a traceback system and know the
date of harvest, the farm identification and chain
of custody from farm to receiver. It would be
delightful, but may not be totally practicable in
all cases.
That is the end of the slide
presentation. One other story that I gave at
Grand Rapids, I would like to repeat here, because
it deals with what happens when there is an
illness associated with produce and helps show, I
think, the goal and traceback. My normal job is
with, I'm the director of the division of field
operations in our field organization. My job is
to not only give customer service to the FDA field
office that are trying to handle imports, but to
give customer service to imports that have
problems with us, and want to learn the rules. My
44
people and I are very serious in returning phone
calls as quickly as we can. One, as we all do, I
was having a bad day, there were a number of
crises going around. I get a call at nine in the
morning, I don't get a chance to return it until
very late in the day. In speaking to the man;
Sir, I am sorry I got your call earlier today, I
am sorry I am so late reporting back to you, it
has been a very busy day. I'm having a bad week.
This was during the time of one of the incidents I
think Stacy talked about, the hepatitis in fresh
strawberries that were, they were processed
stawberries, processed in the U.S. went through a
food service operation in the States. The
strawberries were grown in Mexico. When I said I
was having a bad day, there was silence on the
other side of line. He told me I'm one of the
major importers of strawberries in Mexico. He
said you think you're having a bad day. He had
nothing to do with supplying the strawberries to
this processing facility in California. He
claimed that his farms where he purchased from,
some of which he actually controlled and owned,
were nowhere near the areas where the strawberries
45
that may or may not have been the cause of this
incident were grown. But nonetheless, I'm sure
with a bit of exaggeration he claimed he was
having trouble giving his product away that week.
I am sure it landed beyond that week.
So think about that when you think
about the effort that might be needed on an
industry-wide basis to traceback, and the effort
that might be needed to work with state and
federal trade organizations to make President's
Initiative as effect as we all can.
With that, I think we open it up to
once again to Beverly.
BEVERLY KENT: Please, since we are,
there is a transcriber, come to the mic and
introduce yourself.
DAN DONAHUE: My name is Dan Donahue
with New York State Board of Horticulture
Association.
Tom, I would like to refer back to
some of the prior discussion. You refer to the
identification process, to develop a strategy, for
specific commodity groups, we began a further
discussion to add more to that list. We were
46
wondering about the viability of that strategy.
THOMAS GARDINE: Do you know when we
issue a federal registered document asking for
comments, you open yourself up to any advice
people want to give you. And certainly should you
want to comment on the viability of that strategy,
it would be totally appropriate to do so at that
time.
DAN DONAHUE: Thank you.
THOMAS GARDINE: Or at this time if
you want to make your comments now.
DAN DONAHUE: I will make them
later.
UNIDENTIFIED SPEAKER: Are you
taking comments across the board or going to go by
section?
THOMAS GARDINE: Please, anything
right now, comments across the board. Once,
again, please if you want to make your comments
about what we said, you do have to go to a
microphone.
BILL POOL: I'm a corporate manager
for food safety regulations. My comment is
related to traceback. Certainly that's a hot
47
topic in the food business, being able to go back
to the source, trace the product from the consumer
right back to where it is produced. I think it's
an honorable intention. When it gets down to
reality, it is very, very difficult, unless it is
in a can or carton or some other container or
unless the retail industry and the produce
industry significantly change or the method of
receiving the product or displaying the product.
We don't want to eliminate customers from our
stores. It is all well if we go back and want to
know where the apples were grown, unless it is
packaged or it is displayed on the vending
machine, unless every customer that enters a
retail food store in the United States wears
gloves, tracebacks are not going to give you your
answer.
Let's assume I'm a shopper with
hepatitis A, and I walk in and touch a product,
you come by and buy that product and three days
later feed it to someone in your family. 12 days
later they are experiencing symptoms of
hepatitis. We can traceback this product, it came
from grower X. It wasn't grower X, or grower X's
48
employees or handlers or processors or
transporters, it was me, the customer, 3,000 miles
away from where the product was produced that was
the cause of the illness.
I think you have to be very careful
how you try to traceback or link the process. You
are liable to put a tremendous negative burden on
the grower that has absolutely nothing to do with
it.
THOMAS GARDINE: Let me just respond
to that. Please stay at the microphone for a
moment. First of all, we recognize that, I don't
think there is a public health official in this
room who would automatically jump to the
assumption that the problem occurred on the farm.
But do you have any suggestions or thoughts about
better ways to address this, other than the fact
that it is going to be hard. We all recognize it
is going to be hard.
BILL POOL: Again, unless you limit
the bulk displays of produce so everything is
packaged in some kind of container that can't be
penetrated or entered in any way, unless the
consumer final gets it home, you're going to, you
49
are going to look at a huge, huge shift in the
retail produce. We took a long time to get away
from packaged produce. It is a real positive,
from a customer perspective, to see product out of
the package or can. It would be a huge shift in
consume behavior or retail behavior. I certainly
don't disagree in what we are trying to
accomplish.
THOMAS GARDINE: Please remember, I
also recognize that there is some produce where
this is more practicable to do that than the
others. One of the things we were talking about
on this is bins of displays for apples and other
type of fruit like that. What we would encourage
people to think about is maintaining good records
as far into the distribution chain as is
possible. Not that we as public health officials
would automatically assume that the grower was the
cause of the problem, but at least we can focus on
a problem and go to the grower and take a look and
see if we could eliminate them immediately. But
we are just saying think about it. We know it is
not practicable for all produce, but please, try
to do the best you can. We think that is good for
50
industry, even the retail environment, and good
for us. We do understand the way produce is being
displayed now, it is not totally practical to get
down to the end point in all produce.
BILL POOL: Which again that would
be questionable what you are trying to do even.
Getting back to bins of apple, common retailers
don't segregate apples from growers in bin one, to
apples in growers of bin two. You may have four
suppliers in a specific bin.
THOMAS GARDINE: Yes, there may be
some value in knowing which four growers may have
been in the bin when the illness occurred. Even
that information would help state people, for
example, in trying to evaluate the extent of the
problem.
BILL POOL: I think you have to look
at cost benefit ratio, what is the cost, and what
you actually get out of the process.
THOMAS GARDINE: Understood. Let me
tell you your comments were very similar to things
we heard in Grand Rapids.
PAT TAYLOR: I have a comment and
reaction. I'm a farmer, and I just wonder, are
51
these microbial hazards washable on the produce?
And if so, doesn't the consumer have a
responsibility to also wash this product when he
gets home?
THOMAS GARDINE: Yes, and this GAP
for growers is only one aspect of what is being
done. We are also developing, through our retail
food code, guidance for restaurants where the food
is handled. And we will also be developing a
consumer education program. But what we are
saying here, we believe the grower does have a
responsibility to do what they can to minimize the
risk, knowing that it's unlikely they can totally
eliminate it, and there are indeed
responsibilities all along the food distribution
chain.
PAT TAYLOR: I agree with that. I
just also like the idea of the unpackaged produce,
I hope we don't have to go to packaging.
BEVERLY KENT: When the FDA takes on
an initiative like this, we also have a public
affair specialist in out district office who
spends a lot of time educating consumers. In one
of the packages, the FDA blue folder, you will
52
find some of the consumer material we have
available. We make an attempt to educate the
consumer as well.
RANDY WORBO: My name is Randy Worbo
from Cornell University. You specify the need for
adequate sanitation, hygiene for workers. You
also stress the need for toilets and positioning
of toilets in the field to prevent untreated waste
from getting into the crops. Wouldn't it be
better to place the guidance, recommendation on
the use of untreated waste, period? Because it is
a transmission of human, commonly from animals and
humans that get in the system because workers are
going to be going in the fields. Sure, it is not
going to be on top of the produce. The workers
are going to come in direct contact. And what
happens to the sanitation and hygiene with the
workers that come back from the toilet and do not
wash their hands and they are picking the
produce?
THOMAS GARDINE: I think rather than
comment on that, I will be honest with you, I am
not prepared to.
Joyce, do you want to try to talk to
53
that? We now have it down as a comment and
something we will be considering. This is a
public town hall meeting.
RANDY WORBO: It is just a
question. Now as for 40 to 60 days as being
adequate, I'm not familiar with any research or
data that is available on the survival of fecal
pathogens in untreated manure when they are spread
on the crops. 40 to 60 days prior to harvest may
not be adequate to eliminate the pathogens. When
the workers go into the field, it is going to be
on their shoes, on their hands, and there is your
transmission right onto the product, especially
for unprocessed fruits and vegetables such as
lettuce, radishes, anything like that is a major
concern.
THOMAS GARDINE: I thank you for a
comment.
MARK MCLELLAN: A follow-up, Mark
McLellan, I'm director at Cornell Institute of
Food Science. I just want to start by certainly
applauding you in this document. I'm very
impressed with the scope and depth of what has
gone into the printing here. In particular, I'm
54
pleased to see that we are dealing with health
issues in the production of fresh produce. It is
not something they expect to see microbial
contamination in. It is something to address.
On the issue of traceback, I'm
impressed with the thinking there. I agree with
Tom, there is a lot of challenges there in terms
of issues of retail handling. At the same time,
if you have a traceability, even on bulk lot, it
would allow us to at least explore the idea of
potential contamination at the farm or to
eliminate that as a source of concern. And I
think there is some benefit to that.
And then picking up off Dr. Worbo's
comment about untreated manure, I think this is a
very serious concern. It is one place in these
guidelines where we raise a flag, and that is a
fact that we do have a serious potential source
for human pathogens in untreated manure, and the
fact that we are dealing with a contamination
problem, it makes no sense to allow untreated
manure to be used in the same area as fresh fruits
and vegetables, until such time as we have
scientific proof that shows effective treatment or
55
effect procedure of laying down, maybe it is 200
days, maybe it is 120 days. Until that is shown,
it simply should not be allowed.
STACY ZAWELL: Stacy Zawell, with
United Fresh Fruit and Vegetable Association. I
would like to react to both previous comments on
compost and traceback, or not composting actually,
I guess there is a number of points that make that
a very difficult area to deal with in terms of
food safety. We know that, in fact, pathogens do
exist in manure, and so the use of treated and
untreated manure must be done very, very
carefully.
The point is, if in fact we decide
then we should not use untreated manure, we should
compost, we do not know what sufficient composting
is. If we don't know what sufficient composting
is, the risk is that you don't get rid of it,
because it gets a heat treatment. What we need to
do is make sure what type of manure you are using
and you are using it very properly. Because it
may be, in fact, that it is common practice in
some instances to use uncomposted manure, there
may be absolutely no definitive risks of that. We
56
can understand for public health, when you apply
untreated manure to certain orchards well before
harvest, and it gets worked into the ground and
before crops are even planted, this happens, so
the risk associated with that is not well
understood. And as well, intuitively many growers
can go ahead and make the decision that untreated
manure may be riskier than they want to get
involved with. That intuition should not be the
basis of policy. The intuition should be up to
the operator itself. Policy should be placed on
sound science not intuition.
JOSEPH FERRARA: Joe Ferrara,
Agriculture Markets, New York State Agriculture.
Just a point of interest. We have done extensive
sampling this year of cider in cases where there
is e. coli present in association with apple
drops.
STACY ZAWELL: I certainly
understand that when we are talking about apples,
we are talking apples and apple cider, those are
two completely different things, using drops for
apple cider production is different from picking
the apples for home market.
57
It's something, you know, Tom, as
the industry-wide guidance, we helped to develop
with 20 other organizations, we addressed the
issue of traceback because it is such a very, very
difficult issue to deal with. But the industry
recognized for many, many reasons they benefit by
having effective traceback systems, because then
you get to be, rather than being a commodity wide
effort, you can actually focus on the grower, you
can focus efforts on food safety on a particular
spot. There can be a lot of economic impact
implicating an entire commodity. Rather than
doing that, what Bill Pool was saying, and you
emphasized in your statements, it would be very,
very important to have some very scientific
information.
I've done a lot of going around
terminal markets, a lot of like Bill was saying,
we have this tradition of having open produce
environments. Produce departments in the grocery
store is the number one reason why people pick
their grocery store. It is very tactive, it is
very beautiful. We need to preserve that. I
think it is very difficult, one of the
58
difficulties is I noticed in talking to a lot of
people who run terminal markets, I look at their
purchase orders, I say show me something that
comes in, show me the information. It says 50
eggplants, that is what it says, there is no other
information on there. And, in fact, common
practice is, if they, instead of getting 50
eggplants, they get 45 eggplants, in all
likelihood, they call up to their other neighbor
in the terminal market, I need five to fill this
order for the supermarket. It is a very, very
complicated process.
My point is simply that it is
easiest for the grower to put something on at the
source, that means nothing if we don't have
communication along the pathway. We are working
very, very closely with our partners, our other
associations who represent the food service and
retail environment to achieve or, you know, focus
on getting a little bit better in this process.
It's a very, very long road for us to take.
THOMAS GARDINE: I would comment,
Stacy, nothing you said contradicted anything we
know about the process. To make this work we need
59
communication at every step along the line of the
distribution chain in order for positive lot
identification to be effective in limiting the
specific problem.
MARVIN PRITTS: Marvin Pritts,
Cornell University. The issue of manure
management is a difficult one. It has
implications beyond food safety. I think we need
to be aware of those when they start to address
this issue, for example, manure management is
probably one of biggest environment issues we
face. Livestock farmers in particular tend to
concentrate the manure and not have any way to
dispose of it. The good way to dispose of it is
to use it back on their crops. If we start to say
you can't use manure in agriculture because of
food safety, it is going to lead to perhaps other
environment issues. It might be greater than the
risks involved with the food safety.
And specifically there is the issue
of the organic farmer who relies on manure for
their fertilizer. There is a significant number
of organic growers in this area alone who have
certain guidelines and regulations put in place in
60
the manure management. It would be a very, very
great hardship on them. We need to keep that in
mind when we look at the progression of these
guidelines.
THOMAS GARDINE: Thank you.
ANU RANGARAJAN: Just a follow-up.
My name is Anu Rangarajan. I'm with Cornell.
Something that concerns me, and I know several
other growers, is irrigation water. Many of these
growers are pulling from surface water, they are
within watersheds. When we are addressing those
produce growers in the state, I think we miss part
of the problem. And I think we need to expand
this effort to include livestock industries,
because, how they are handling manners. In
effect, to irrigate the grower might have to be
pulling from the surface water. They have little
control of that water because they are
downstream. I think that is one of the challenges
with traceback efforts. Testing of irrigation
water isn't easy, it is expensive. At what point
during the season do we test irrigation water?
These are missing links.
To impose these types of comments
61
and suggestions to growers, we don't have the
backup to be making wise type testing
recommendations. And informally we have done
testing over time of irrigation water in a
particular watershed. And picking at different
points along the stream we detected Salmonella in
one area, and we didn't detect in the other. We
don't have a sense of what is a real risk to the
growers that would be applying this as surface
area water in their crop.
THOMAS GARDINE: Thank you very
much.
Beverly has indicated to me that she
wanted to break at 11:30 for lunch. I'm going to
take one more question and then please hold your
questions for the afternoon when it is going to be
wide open for everyone, and our panel will be back
in front of the room.
JODY SMITH: Jody Smith, Environment
Solutions. We have been doing some preliminary
testing with ozonated water with local producers
in the Buffalo area. I was wondering if you
recognize ozonated water as effective cleaning
process? Do you recognize ozonated water as an
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alternative cleaning solution?
THOMAS GARDINE: I am not the person
to answer that question. If you wish, if you have
a business card, you can give it to me and we will
give you a formal response on that.
BEVERLY KENT: Okay. We will go
ahead and break. It is 11:45. So if you could
return at 12:45. We also have 3x5 cards available
for anyone who would like to submit a question.
(LUNCH RECESS WAS TAKEN)
BEVERLY KENT: Just a few
reminders. There is a sign-in sheet out at the
registration desk. There is a sign-in sheet out
where Tom is sitting. If you could please fill
that in, it is a great help to the transcriber so
that you don't have to spell your name and
indicate your affiliation. So please take the
time to do that. And when you do go to the mic
for questions, if you are giving a presentation
this afternoon, please speak clearly and slowly,
not really slowly, not really fast, and also get
practically right up on the microphone like I am.
The microphones are turned up as loud as they can
be turned up. If you can't hear, please raise
63
your hand and we will let the speaker know.
Now our next speaker today is from
USDA, he's Rick Gomez. He'll talk a little bit
about the role of the USDA.
RICK GOMEZ: The role of the USDA --
by the way, I am Rick Gomez. My agency, the
agency I work for is a cooperative state research
education service which is the federal partner of
the Federal Department of Agriculture. We are now
in the extension service throughout the United
States. Let me tell you about what I think the
role of the USDA is and will be for a long time.
We at USDA, through our various
systems, agencies, partners, touch each and every
county within this country. We also are involved
in the territories and through the foreign
agriculture services, in foreign countries as well
in the field of agriculture, not only within the
U.S., but also outside of the U.S. So we have a
tremendous opportunity, and also a very heavy
responsibility to make sure that this fresh fruit
and vegetable initiative works. We also can be
and will be and will continue to be providers of
science so that this initiative can work. We and
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the FDA are full partners in this. It may not
seem at this point, but we are full partners.
There are several agencies that I
want to mention and that doesn't mean that the
other ones are not important within USDA as far as
this initiative is concerned. But there are some
that are critical. The ones that are critical are
the Foreign Agriculture Service, through the
International Cooperation and Development Group.
And they are the outreach and educational part of
the Foreign Agricultural Service. And many of
you, or some of you, if you are from Cornell, may
have been involved in going and doing some
educational programs or assisting in their
research programs in other countries. This is
through the Office of International Cooperation
and Development. So we do have a mechanism to
carry out educational programs in other countries
through that, as well as through USA ID Agency for
International Development. But we work very
closely with those two.
The other one, other agency that is
very much involved now in protecting American
agriculture is Animal Plant Health Inspection
65
Service, that will also continue to be involved
and will be more involved as this initiative
progresses. They are the check points at the
borders, so they will be helping FDA in their
efforts as we progress in going to the
international realm with this initiative.
Another agency that is very
important and it's also like ours, like the one I
belong to, reaches down to the community level and
that is the Natural Resources and Conservation
Service, which is basically the new name for the
Soil Conservation Service. But they wanted a
broader aspect in the environment, so Natural
Resources and Conservation Service. Through their
water and soil conservation districts, they touch
the farmer at that point. As a matter of fact,
they are the agency that does approve farm
management plans if they are involved in an USDA
farm program. So they have a way to reach the
producer at the local level.
My agency is made up of the
Agriculture Extension Service and the Agriculture
Experiment Space, and those two groups, and in
some cases one individual belongs to both, are
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very critical. We can, through the extension
system, identify some of the gaps that are
existing, bring it back to research, research can
do their work on them, and as extension people we
can then transmit that knowledge through
educational programs or through technology
transfer, either way, to the producer.
So that we do have an excellent
mechanism through which we can follow-up with
that. But it doesn't stop there. If it stopped
there, this initiative would be dead in the
water. What we need to do is continue. And we
have been working and will continue to work with
industry, the agriculture industry. We must be
partners. I think Tom and Stacy mentioned this
before, we must be partners for this to work. It
will not work unless we work together and make
some commitments.
It is a pleasure to see many of you
from industry, from the experiment station, and
from extension here. We need to work together.
Let me give you an example of a program that I
think we might be able to use as a model or as
part of a model to base this initiative. And that
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is one that I think has been very, very successful
in the United States. It has been very successful
outside of the United States as we carry it out.
It is an integrated pest management program. It
is a system that, it is a program that is based on
science. It is a program that is voluntary. And
those two facets are, I think, critical so that
this initiative can proceed and be successful. It
must be based on, since it must be voluntary and
practical. IPM is, and IPM not only is, has been
a program that has in effect improved the quality
of our food supply, but also improved the economic
viability of the farmer. We hope that this
initiative can do both. IPM has also generated or
engendered a new industry, or nurtured an industry
that was fairly weak, and that is agriculture
consultants. That is a viable industry at this
point and will continue to be. Maybe those
consultants will also take on responsibilities in
the food safety issue as we proceed. That is a
very successful program. As a matter of fact it
has become a marketing program as well. We now
see produce at the grocery store, labeled produce
under IPM or IPM product, and that is what this
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initiative may become later on.
By the way, we are almost at the
point where 70 to 75 percent of all U.S. grown
crops are under IPM. And to me that is a big
step. We hope and will have by the year 2000, 95
percent of all U.S. crops grown will be grown
under IPM programs.
So I think USDA has not only a
partnership role with FDA, but also we must be
partners with industry. We reach people down to
the local level, we must start the partnership
there. Extension and the experiment station
systems must tell us what is needed out there in
agriculture. We must, if it is researchable do
it, and base our programs, therefore, on sound
science. If it is not based on sound science it
will not work. And I think that point has been
made before.
So, our role here in this conference
is minimal at this point. But we, and hopefully
all of you through USDA, these hearings, FDA, the
experiment station system, the extension system,
will tell us what is really needed down to the
producer level. We will get there, believe us.
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It may take a few years, couple, three, four
years, but we will get there. And it may not be
for all 338, that is the number we have heard, of
different vegetable and food crops grown in the
U.S. or foreign countries, but we will get there.
And hopefully we can all do it together in a
practical way which does not place an economic
burden on the producer, yet protects us the
consumers. I know you producers are also
consumers, so it is for your benefit as well, and
you know it. We know it also. Thank you.
BEVERLY KENT: Thank you, Rick. We
will go ahead and begin our industry group
presentation. And to start the presentation we
have Stacy Zawell from the United Fresh Fruit and
Vegetable Association.
STACY ZAWELL: Thanks, Beverly. I
would just like to again start my comments out by
letting you know that United is an international
trade association that represents over 1,100
growers, shippers, wholesalers and brokers of
produce, and we also represent industry
suppliers. And I am going keep my comments to a
minimum, because I've got a number of people from
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the industry together to talk and give you their
reaction to the guidance.
I would like to preface my previous
comments and these comments by stating that our
involvement is to insure practicality and
reasonableness through this process. It is not to
fight the process and, in fact, United has led the
effort to develop an industry-wide guidance
document on food safety with 20 other produce
associations representing many different regions
and many different commodities to demonstrate to
you that, in fact, we are very engaged in this
issue. We want to work very closely with you, our
members and others beyond that to insure and
increase the awareness of this issue and make sure
the response of food safety in their own
operations are very focused.
What we want to do is going to be
difficult. I think with this general guidance
too, one of the things we struggle with is how you
take guidance that has to stop at science and
implement and help an operator use this guidance.
That's one of our next efforts, to develop these
tools and also work with you guys to make sure
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that these efforts are effective and that we can
reach the actual user, the end user. But, well,
this guidance is going to be very, very valuable,
in all of these efforts, whether it is the efforts
we have done, whether it is the efforts the
Western Growers Association and International
Fresh Cut Produce Association have done and
regional commodity groups such as California
Strawberry Commission. Each one of those programs
have been done by the industry and for the
industry, and, therefore, very practical, and I
urge you to make sure this is all done in that
way, because if it is not, I'm afraid, my fear is
that it is going to lack credibility, and people
that need to use it and need to have their
awareness increased, are not going to benefit,
because it is going to have silly recommendations,
if you will, such as covering a reservoir. I
think it is important that this guidance is
practical, reasonable and makes sense.
With that, I just want to state that
as we have done through this process, United has
taken, made the effort to develop a coordinated
response by the industry at each one of these
72
meetings in order to capitalize on that and
contribute to make this effective for you guys as
well as for the industry.
So, Beverly, if you want to go
through a list of the number of people we have
invited to speak, go ahead, and that will end my
comments.
BEVERLY KENT: The next person for
the industry presentation would be Dan Donahue
from Stone Fruit and Strawberries, New York State
Horticulture Association. Thanks.
DAN DONAHUE: Thank you, Beverly.
Thank you for the opportunity to speak today and
give testimony on behalf of the membership of New
York State Horticulture Association. For those of
you not familiar with us, our organization, it is
comprised of various packers, shippers, growers,
people interested in the commercial fruit industry
in New York State. Our membership comprises
really all New York State, plus out of state
people as well.
Before I begin with my specific
comments, I want to make it clear that our members
are quite concerned about this issue. We are very
73
concerned about the safety of the food we grow.
We believe we have a very safe food supply, but we
want to work towards making it even safer. We
consider this a very, very valuable process, a
very important process.
Secondly, we understand that this is
the beginning of this effort, that this is a draft
document and we are very interested in commenting
on it and contributing to its progress, but we are
at the beginning of a process and we are not at
the end of it. If you keep my comments with that
perspective, I would like to eventually get to a
few comments.
Stone fruit and strawberries perhaps
contrast packing practices with New York even with
the rest of the country. First, the guidance
development process, and I know you have all heard
this before, but I'm going to say it again,
referring to the panel that we need more time, the
industry needs more than a week to respond to an
effort like this. It is a 50 plus page document,
very involved, and as been said before, the devil
is in the details. It takes time for us to go
through this and to pick it apart.
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So as we proceed with this
initiative and the future initiatives that take
some mercy on the industry and our response time
and allows us more time to really do an
appropriate job in dealing with this.
We also think in the development
process that the folks at the government level
really need to understand agriculture around the
country and the diversity of agriculture around
the country; that could be farm visits to packing
houses, tours of the industry, certainly our
organization will be more than pleased to
facilitate those efforts. We will cooperate and
do everything we can to maximize your education
and the concerns and the positive aspects of our
industry. We also think that the USDA really
needs to have a very visible role, particularly at
the farm and packing house level.
With this effort it is the USDA that
is close to the agriculture industry, and has a
historic understanding of how we work, what our
problems are, what our needs are. We really
prefer to see USDA people come onto the farm or
into the packing house, rather than, honestly, FDA
75
people at this point, until the point the FDA are
experts in agriculture. We certainly will be
pleased to see them become experts. We all have a
wide range of responsibilities, certainly the USDA
is really already at that point.
Existing regulations, let's make
sure we consider existing regulations. And an
example of this will be the field sanitation
regulation that we live under in agriculture in
the OSHA regulations. We don't want separate
regulations from this group. If the OSHA
regulations are not sufficient, then let's change
OSHA regulations, let's not put a second set of
regulations, i.e. guidlines to this.
Speaking to the point of regulation,
I heard clearly Tom's comments very clearly that
these are guidances, this is not regulations. We
understand this. However, we also know how things
can work out in the industry. And our concerns
are as soon as the federal government comes out
with a guidance with recommendations on paper,
that they will, in a de facto sense, become
regulations; as certain parts of the industry,
perhaps the buyers adopt them and specify them.
76
We are not necessarily against this, we just want
that to be taken into consideration when we
develop these guidelines. We need as much rigor
in terms of the science behind guidelines as we do
with regulations. We cannot lapse in our desire
to have a good science.
Sound scientific background is what
we are asking, because several things could
happen. One, again the industry could develop
these, growers, packers, shippers will have to
abide by them, because of the market. Or, two, we
have a set of guidelines on the books and as soon
as the next scare comes along, whether it is
justified or not, congress could direct that they
become regulation very quickly. We want to be
careful that we are well prepared for that
contingency.
I mentioned science, it must be
based on science and I will be frank with you.
The current document does not have much science in
it. As an agency, we have started a process where
we are working towards a final document that needs
to have more science in it. We can't afford a
shotgun approach to this issue. It is very
77
important where we put our resources, be it grower
resources, packing, shipping resources, government
resources, to try to pinpoint areas of
contamination or greatest threat of
contamination. We want to make sure those
resources are sufficiently used. This is
something we need to keep in mind, everything must
be based on science, research. We think we have
an unbiased viewpoint. We are sitting in the
middle of probably the great agriculture research
institution in the country, of course that is an
unbiased view. In any case, money needs to come
here as well as other equally good research
institutions to start answering these questions.
We need to start working on it and the regulation
of guidance, and any future activity must be based
on that science.
At this point in time we wish not to
see commodity specific guidance, of course this
goes back to a question I asked of the panel
earlier. We think a general approach is more
warranted at this point, considering the level of
scientific knowledge we have. We are concerned as
soon as we point a finger at berries,
78
strawberries, apples, or at a specific vegetable,
that sales are going to drop in that category for
no justification. At this point the science is
not good enough. We feel going to commodity
specific is not prudent. We would like to see
that backed off to a general guidance and let the
industry and research work from that point.
Something to consider here in the
northeast is the prevalence of small farm markets
or farm stands. The fact that the food system in
the northeast is a very important component. We
are not all in grocery stores, big wholesalers,
large distribution centers. When it comes to
issues like control of contaminants, that raises
back previous issues. This is a very important
consideration to take into account.
Just some specific comments about
stone fruits and strawberries in New York. In
terms of manure use, of course stone fruits are
tree fruits. Manure is often used preplanted.
Oftentimes a crop is not taken off a tree until a
number of years after it is planned. Manure is
used in berries, in some instances as a
fertilizer.
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Also you have to remember
agriculture in the northeast is heavily dairy
oriented. It is quite likely your fruit farm is
going to be contiguous to a farm, dairy operation.
It is necessary to take that into account, again
with research as to how susceptible, say, my fruit
farm is if it is next to a dairy farm, what steps
I need to take, what they are going to cost me,
what is the real threat, what science says the
real threat is, is it in the form of irrigation.
Definitely strawberries are grown differently here
in the northeast than they are in Florida or
California. We do not have a plastic culture in
New York. Overhead irrigation is almost always
necessary. It is not for irrigation in terms of
water status, it is for fruit quality, it is
really key to the industry.
This is a contrast to some other
growing regions of the country. We take this into
consideration. Irrigation in tree fruits, on the
other hand, is some form a trickle irrigation, the
water source can be municipal wells, streams,
lakes, ponds, swamps; you name it, it is there.
And this all needs to be taken into account.
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Crop protection, again the water
source for crop protection sprays are all of those
sources except swamps. Again the water spray is
not usually tested for bacteria. It often is
tested for pH and that is it. The question comes
who is responsible for the testing. A lot of
reliance on the document is placed on the grower
to test, and again this is quite a burden to the
grower. And we need to look at, perhaps, the
government to be, or water districts or other
municipal entities be looking at this. If you are
drawing water out of a stream, what happens if
there is something going on upstream? Is it the
grower's responsibility to deal with that? That
seems to be a difficult position for the grower to
be in.
Stone fruit and strawberries,
generally, in New York are dry packed. The stone
fruit may be run over sizing equipment of various
level of technology, often handpack, there is very
little water involved. In terms of handling stone
fruits, there is no hydrocooling that is going on
in the northest. Generally stone fruit producers
are small operations doing some wholesale work,
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but not supplying the volume out of shrink zipper
that you would see in California, for instance, or
Florida.
So, again, something to take into
mind as we develop this, again, we can't be so
specific that guidance tailored to the huge
California industry may well not be a fact almost
guaranteed not be appropriate to the New York
industry. This is something that needs to be kept
in mind.
Worker hygiene, again we have OSHA
regulations along these lines. There is no point
in having guidance that is either opposed to or
somehow different from the OSHA regulations. If
you're familiar with the regulator situation in
New York, it is mind-boggling the number of
regulatory agencies with access to the farm, with
similar responsibilities, similar tests. You can
get visits on a single day from three different
groups to visit your labor camp all looking for
different things, all really looking for the same
thing when it comes down to it, with a slightly
different twist.
Again with field sanitation, there
82
is really practical concerns with the health of
your workers, how do you address that, how do you
address the privacy issues. Generally folks that
are working on the farm, particularly in a
piecework, are there to work. If you ask them how
are you feeling today, are you sick, maybe you get
an honest answer. You will get it once, because
they will realize they are going home and in that
case they are not making any money. They are
going home, which means that is it; everybody will
be really healthy. The rest of the sentence
whether they are or not is something to keep in
mind.
In terms of traceback issues, again,
it's very positive that we work towards a
traceback system. Again, keep in mind, often the
nature of the, a lot of small farming in the
northeast in the New York State, and a lot of farm
markets and the difficulties that could be
presented with those situations. We need to take
them into account.
With that, I will close my
comments. Again I really appreciate the
opportunity to have a say for my organization and
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we look forward to working with you in the future.
THOMAS GARDINE: Could I ask you to
stay up a moment. I would like to get some
clarification. And, of course, given in one case
a bit of rebuttal.
Number one, your concern about
overlap with the OSHA regulation, I think we would
want to stress that the OSHA regulations are for
the health and safety of the workers. While there
is going to be frequently an overlap, we seriously
believe that a guidance document like this is
intended to show the growers what needs to be done
to protect the product from microbial hazards. A
bit of repetition may be of value, but let's
remember both OSHA, the OSHA regulation and this
guidance document are attempting to address
difficult concerns.
And as for your concern with the
health of workers, once again, this is something
we heard very much, and I would just like you, if
you are thinking of putting in a specific written
comment, to bear that point in mind, the focus of
the OSHA regulations. And, please, when you talk
about the health of the workers, yes, we realize
84
that people are paid piecework, we realize that
people don't like to be sent home when they need
these dollars, but we also realize that they are
frequently the last person touching fresh produce
before it gets to the consumer. And not
mentioning this, not mentioning the need for
certain concerns with the worker's health puts us
perhaps in the position of appearing to imply it
is unimportant. If people with diarrheal
illnesses or open lesions touch food, that is a
very difficult position for public health
officials to be in.
DAN DONAHUE: In response, I
definitely understand. I think my industry
understands that. It is just in a practical sense
for the grower, packer, shipper, it is a difficult
issue to deal with. That is what I wanted to
convey.
In terms of duplication or restating
OSHA regulations, again in a practical standpoint,
I'm referring back to an earlier draft of the
guidelines, they had a figure of five facilities
should be provided with five workers or more. I
don't believe that is in the last set of drafts,
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the OSHA standard was ten workers or more, there
is a discrepancy. Understanding that these are
guidance, there is a specific OSHA number that
growers know very well. So here's another number
out here. Now I think in the latest version it
says should be provided for all employees. I am
not saying that is a bad idea at all. I'm saying
there are existing regulations growers are used
to, and we want to get our act together and be
coordinated in what we do. We understand the
importance of it.
THOMAS GARDINE: Okay. Thank you
very much.
BEVERLY KENT: Steve Reiners.
STEVE REINERS: I'm going to come up
here and speak so I can keep everyone in front of
me except for you. I'm sure if you are like me,
before you went out to lunch you washed your hands
more thoroughly than you normally do. I've been
an assistant professor here at Cornell working
with vegetables. Prior to that I was six years at
Rutgers in New Jersey in a similar position. I
would like to comment on three different aspects
today. First is on manure use, second irrigation
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and final post harvest practices in crops.
First, to give you an idea of the
diversity of the vegetable industry in New York
State, it is about 140,000 to 150,000 acres. It
is worth roughly 300 million dollars each year.
This will be the only meeting you will have. If
we take all the states from Maine down to
Virginia, we are looking at an industry worth well
over a half billion dollars, encompassing 350,000
acres. When we are talking about vegetable crops,
we are talking about crops anywhere from 35 to
50. When I was in New Jersey they used to be
proud of the fact they grew up to 50 different
vegetable crops, which includes a lot of herbs.
We are talking about a very diverse industry when
we are talking about vegetables. If I am a farmer
on Long Island and growing tomatoes, for example,
as a single crop, when and how it is grown is
going to be very dependent on what the market will
bring. You better believe I am going to grow them
on stands and with trickle irrigation. If I'm
growing processing tomatoes in Pennsylvania, I'm
going to have the least amount of input as I can.
In regards to manure, is manure used
87
on vegetables crops? Yes, it is. To what
degree? I really can't give you an answer, I
can't. It varies why is it used and why it is not
used. I think probably the most important aspect
here is how the, how close the manure source is to
the farm. You are not going to ship manure a very
long distance, it is not worthwhile to do that.
Growers have relied for years on the soil quality,
issues of using manure as an increased organic
matter, increase soil till, reduction of soil
compaction, as a nutrient source.
For the most part for vegetables
crops manure is used, I would say put down usually
in the spring and incorporated in the soil. Since
most vegetables, the majority of vegetables will
take at least 60 days from the time it is planted
until the time it is harvested. If we are looking
at what is that safe period from the time
application to the time of harvest, for most of
the vegetables crops, 60 days is a minimum. If we
start talking about a minimum of 120 days between
application and harvest for areas in this part of
the country which are much cooler, 120 days is
getting into the entire growing season. One of
88
the problems we would have then is manure would
have to be applied in the fall or in the winter.
And if that is done, it raises the possibility
that the manure nitrates, which of course are very
serious issues could be lost either to ground
water or to runoff and other pathogens could also
be lost as well. Nitrogenous matter of the manure
would be lost significantly if we had to put
manure down and allow for a longer period of time
between application and the time it is going to be
harvested.
I am sure everyone in this room
knows about manure that is used in agriculture.
There might be some, perhaps, media people that
are out there today using manure in agriculture.
It is certainly nothing new, it has been done
thousands of years and probably up to this
century. It was really the only source of
fertilizer for most people. With the advent of
synthetic fertilizers, less manure was used, and
really up until the 1980s, with the exception of
organic growers who continued to use organic
manure and compost foundation for their production
until the '80s, manure was at a minimum at that
89
time. With land grant colleges like Cornell
Cooperative Extension, the use of manure by
growers was encouraged. And to tell you the
truth, one of the best things I have seen happen
in my ten year career is the use of manure in
vegetable crops because of the things I was
talking about in terms of what it can do for the
soil. And as a potential pathogen problem, it was
really not an issue for me and probably for most
of the industry here, until just about a year ago
at this time when a cabbage grower was approached
by a buyer who was buying cabbage or coleslaw and
was asking if this cabbage was treated with fecal
matter. That is the first time I heard of animal
manure called fecal matter. In fact, we have
other names for it, not usually that.
Because of questions that came up
from some of the growers, a group of us at
Cornell, Marvin Pritts, and a few others got
together and tried to come up with some guidelines
growers could use. I brought a couple copies of
this presentation for foodborne illnesses. We
need to base this on science. I know how hard it
was to find the information that we needed to go
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in here. Is 60 days enough? Is 120 days better?
Is 30 days okay? It is hard to find that
information. I know that a lot of work is going
on at colleges and universities around the
country. We are doing work here. More work needs
to be done to base this on sound science.
We are also in the process of
working with the industry developing a survey on
manure use, to find out exactly what vegetables
are grown in this state. And hopefully you will
be able to look at this state and how they are
using manure and what crops they are being used
on.
The bottom line for me, as
scientist, as a consumer and as farmer, am I
concerned about the use of manure on vegetables
crops? I would say with the way it is being
applied now, it is not being side dressed because
it is not an economical way to put manure down. I
am not concerned about manure use. With the
guidelines that have been suggested here and other
places, I think growers are doing a good job.
In terms of irrigation practices,
theoretically using trickle irrigation would
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probably minimize potential pathogen problems in
vegetables. But again we have to look back at the
economics of that. The only time a vegetable
grower would be using any trickle irrigation as
Dan pointed out on Long Island would be if it was
making money. If it's costing 400, $500 per acre
to put in trickle irrigation system on cabbage, it
is not going to happen. The water source that a
grower uses, he usually doesn't have a lot of
choice. If one source is contaminated that's
probably the only source he has. It depends
whether wells are used. In this area wells are
not used because of the great depth you have got
to go. We use a lot of surface water where
potential problems could exist. If we are using
water from streams, and if that stream is possibly
contaminated from a dairy or another animal
operation or even from septic systems, the
question becomes does that grower need to test his
water every time he irrigates. Does that grower
need to test his water when he starts to irrigate,
when he finishes irrigation, if he tests on Monday
does he need to test on Thursday, how long will
that be. We can do tests at Cornell at the vet
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school for $25 a piece to look at five different
pathogens. It becomes very expensive for a grower
to be doing that. That becomes another problem.
In terms of post harvest practices,
again, the primary goal for most of the vegetable
commodities, being something that is extremely
perishable, is to lower the temperature. If you
lower the temperature and cool it down, you're
going to have a product that lasts longer and
quality is going to be better. One of the things
talked about is using wash water that might be ten
degrees higher than what the produce is to try to
minimize any pathogens going into the produce. It
is been standard practice in this industry to use
cooler water. We have recommended the water
should not be more than ten degrees cooler than
what the produce is because we have often for
years worried about possible soft rot bacteria,
things like that that could hurt the fruit and the
quality of that, tomatoes or other fruits could
possible get into. We haven't concerned ourselves
too much with pathogens. I can't imagine a grower
who is growing quality produce would ever be
washing his vegetables in a nonchlorinated
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solution of water. In fact, if you were using
water that wasn't chlorinated, it would be a
perfect way, as has been pointed out earlier, to
spread the disease.
Again, growers, I think, are doing a
lot to insure safety of their products. But again
I just want to point out that we can't over
emphasize the value of animal manure in
agriculture systems. And to move away from that,
or to develop guidelines, perhaps, that are based
more on emotion than on science can certainly be a
danger.
With that, I would like to end my
comments here. I don't know if there is
questions.
THOMAS GARDINE: You have obviously
read the sections concerning manure management.
What specific guidance in there is giving you
pause, concern, appearing to discourage its use,
other than the comments on untreated and
uncomposted manure and the 120 days? Is there
anything in that section of that regulation --
excuse me, I was told if I ever said regulation,
people would hit me, that section of the
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guidance,, and please that was not a Freudian
slip, that is just exhaustion, of that section
that you would like to specifically bring to our
attention? Is there something that you would
think is disturbing and what you believe is very
sound practice?
STEVE REINERS: I would have to look
at it in more detail. Again, just -- well, let
me, I'm going to have to look at that in more
detail. I will make written suggestions.
THOMAS GARDINE: Very well. Thank
you very much, appreciate that. Thank you.
BEVERLY KENT: Next we have Dale
Hemminger, his commodity is vegetables. He's from
Hemdale Farms.
DALE HEMMINGER: Hello. I'm going
to keep my comments brief. The two previous
speakers did a good job of touching on a number of
issues. I'm general manager and primary owner of
Hemdale Farm, which is second generation farm five
miles west of here. We run 2,000 acres, half
vegetables and half grain, and forages for 350 cow
dairy.
There is some, quite a bit of
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overlap here with manure and vegetable interest.
We really want to emphasize we want to produce
safe food. We want to do what is right for our
industry. We also have to be able to survive and
compete. And in today's world that means compete
globally for our markets.
Couple issues I want to touch on
with the application of manure. I do not know
what untreated versus treated is. I believe all
our manure is untreated. We store our manure in
lagoons and we incorporate an awful lot of it to
planting, generally plowing it down eight, twelve
inches. This application gives us a greatly
improved soil till, reduces the use of mined
fertilizers which is very good for our entire
world, and we have documented, seen an improved
quality in the produce, because we think that the
produce ends up with a more consistent supply of
nutrients and has actually received a reduction in
the root rot and some other things in root crops.
The science behind the use of manure
is limited. We really need to look at that. If
60 days is the right number of days between
application and harvest, everything I'm doing
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today is okay. If 120 days is the right number, I
am in big trouble. Our growing season is barely
120 days. We are going to be harvesting stuff
along part of that.
Composting, composting is a
wonderful, actually there is people in the
industry doing a great job. The organic industry
is doing a great job. For our operation, which is
a large scale low margin business, it is
impractical. We have 700 animals on the farm.
Off the top of my head we are probably dealing
with five or six million gallons of manure a
year. So as far as any direct manure application
to crops, I don't know of any. I can guarantee it
is not going on in our farm. I don't know if it
is going on any vegetables in the northeast. I
think that is where you need to focus, people
putting manure overhead or side dressing onto a
crop.
The discussion about irrigation, the
issue of drip irrigation is not practical in our
business. Steve's example is a very good one. If
we were going to stake tomatoes for Franmark
(phonetic) where the potential is four to ten
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thousand dollars an acre, drip irrigation is an
option. You might say why are you concerned? I
think everything that happens in the fresh produce
industry will go on in the processing industry.
We also do some fresh on a limited basis. Drip
irrigation is not practical. It is logistically
improper with 1,000 acres of vegetables. I
traveled to Mexico recently and if I'm going to
drip, I'm going to drip irrigation, I'm going to
hire workers for 50 cents an hour. That's where
economics comes in. We irrigate primarily from a
creek. I would like to know what we need to do to
have confidence in that water supply and right now
I don't know that. We also irrigate from some
ponds, and that is all overhead irrigation. The
mention of covered reservoirs is just not
practical. If I'm going to build a structure that
big, it is going to have tennis courts inside and
generate some income.
And I guess in closing, I would like
to comment, we talk about these being guidelines,
not regulations. I totally appreciate that. I am
hopeful this process is going to lead where we all
want to go and that is a food supply that's safe.
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Our food supply is darn safe now. We need to
identify what can go wrong and identify the areas
where we need consistency in the industry and not
have people doing things wrong. But my business
is primarily selling the food to processors, the
two food processors in New York are Agarlink
Foods, formerly Curtis Burns and Seneca Foods.
They supply to Wegman's, the local state of the
art grocery store chain in this part of the
country, as well Sysco Foods, a national food
distribution company. And while your regulations,
your information is guidelines now, these guys are
going to tell me if I want to be their grower,
then that is what the regulations I'm going to
live by.
So your guidelines for tomorrow will
turn into my regulations, whether it is government
mandated or not. We have been signing
documentation we weren't using municipal sludge
from certain companies for over ten years. There
is not any federal regulations on that, but one
small company in particular based in New York City
decided they wanted this issue addressed ten years
ago and we signed we weren't using municipal waste
99
on their cabbage acres.
In closing I want to emphasize what
Dan said, we welcome you to visit our farms,
particularly during the season, to understand our
challenges. I have friends that have left the
industry, as well as friends that are familiar
with our industry, they tell me there are few
industries as challenging and diverse as ours. I
grew up in this industry, I don't know better.
Mother nature throws us curve balls everyday. We
need to be able to change, move with the weather.
We cannot do this with guidelines that are too
stringent.
In closing I would like to quote
Eisenhower, farming looks mightily easy when your
plow is a pencil and you're a thousand miles from
the corn field.
THOMAS GARDINE: The concern raised
by several people today is what we put out as
guidance is quickly going to be standards that
your buyers are going to demand.
DALE HEMMINGER: Right.
THOMAS GARDINE: The guidance we put
out is not a regulation, there aren't many numbers
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in there, it doesn't say you will test this water
this way. How do you see it as challenging to
meet a guidance document that is so broad in
nature? What sort of documentation might they
require? What sort of hoops and challenges will
they demand of their suppliers based on a document
of this form? What can they point to and say do
this.
DALE HEMMINGER: Well, the --
THOMAS GARDINE: Other than covering
your reservoir.
DALE HEMMINGER: For instance,
composting manure. If we were told we had to
compost all our manure, we would stop using manure
on vegetables, maybe we would stop growing
vegetables. I will tell you right now we would
not economically be able to deal with that. If we
we were told 120 days, we would have to stop using
manure on 75 to 90 percent of the vegetable
products. It is not economically feasible in this
part of country, or apply, which was suggested, in
the fall. In the fall we would have triple size
storage. We have made a step backwards in the
recapture from the nutrients in this manner. Any
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manure applied in the fall in this part of the
country where we have the heavy rainfall and snow
pack all winter, the good share of the nitrogen is
lost, that leaches, goes on into the aquifers,
which they are trying to get away from. Ideally
manure stored, applied previous to planting,
breaks down and crops can utilize it for
nutrients.
Those are the only two examples I
have right off the top of my head. There are
people here from the industry, both of our Coops
and Wegman's Foods that maybe they have comments
where they see sticking points here. Like I said,
we are trying to move in the same direction. We
also need to end up with regulation that the
American farmer can live with.
THOMAS GARDINE: Thank you very
much.
JOE FERRARA: Is nitrogen loss also
an issue with composting manure?
DALE HEMMINGER: It depends again on
the type of composting that is being done.
Whether it is being exposed to the elements means
anytime you have a nitrogen source like manure you
102
turn into compost, putting it down, we have always
got a chance of losing some. It is possible. I'm
sort of stepping out of my field by getting into
that aspect.
BEVERLY KENT: Maureen Marshall, her
commodity is vegetables. She's representing Tory
Farms.
MAUREEN MARSHALL: Good afternoon.
I'm very glad to be here. I'm Maureen Marshall
representing Tory Farms, 11th generation farmer
here in the United States. I farm with my two
brothers. We are primarily fresh market
vegetables, processing grains and two years ago we
added a dairy farm. We currently milk about 750
cows. One of the reasons why we did go into the
dairy business was to have a source of fertilizers
from the manure to use on a rotation crop of the
grain and to use on our land as a way to combine
all the facets of our farming. We are also not
only growers, we also have a packing shed. We are
shippers and we also have a transportation
company, so we take the food, the vegetables from
the field right to the chain store.
We are active in trade
103
organizations. I'm a director of the United Fresh
Fruit and Vegetable Association, a director of New
York State Vegetable Association and many other
organizations. I have a master's degree in common
sense, and my experience is that guidelines become
regulations, and currently working on my doctor's
degree. I have a great concern in the rush that
this initiative has been under, and wonder why
there is so much pressure to act so fast. Are we
disregarding the substantive for the uncertain.
There is so little sound scientific information
about produce and foodborne illnesses, no real
risk assessment and no real public health code
set. Let's do our research on causes on foodborne
illnesses. Have we put the cart before the
horse? I think so.
We need to work together on this. I
need to take this guidelines that I received in
hard copy today and read it thoroughly, respond to
the different practices that you have outlined in
this.
Hearing the comments I have heard
made today, I echo with Dan and Steve and with
what Dale have said, I won't repeat those. I will
104
follow through with a written copy. I have to
thoroughly read this. You need to visit our farm
and talk to the farmers and producers. Our
farming methods differ for the same commodity from
different regions of the country. Here in the
northeast we are lucky for our cold weather, even
though we curse it. Many times our cold weather
helps kills our disease problems. That is one of
the differences from my competitor. I wonder,
have you done a cost analysis or impact statement
on the cost of the consumer or to the grower? I
haven't seen this. Have we done enough to
reeducate consumers on how to handle food. I see
school children not washing their hands before
they eat lunch. I see unproper refrigeration and
handling at picnics, gatherings. In the
consumer's kitchen I see cooking procedures and
cross-contamination between food. Are we not
starting at the right place? Do we not need to
help educate consumers, work with our trade
associations and with our government agencies.
I'm proud to be a grower who has
made and continues to provide the world's safest
food supply to a population who enjoys the ability
105
to live longer than ever. I trust that you will
take your leadership and help us fill in the
knowledge and scientific gaps this guideline has.
If not, I don't see a future for commercial
growers of fruits and vegetable in this country.
Thank you.
THOMAS GARDINE: Thank you.
BEVERLY KENT: Is Walter Blackburn
here? Walter's commodity is apples. He
represents Apple Acres.
WALTER BLACKBURN: I'm an apple
grower and packer and cold storage operator in
Lafayette, New York. It's about 40 miles east of
here. I grow 185 acres and store and pack apples
for several other apple growers. In talking about
the good agriculture practices, I want to
concentrate, our current practices differ from
those recommended in the draft, and are difficult
in complying with the requirements of the draft.
Usually when I take people around
our farm, through our packing house I gloss over
these things, I don't like to point it out, but
today I brought myself to the discussion. I am
not going to address the benefits that the draft's
106
recommendation may bring about. Although having
shipped millions of bushels of apples to
consumers, I added that up, it is several million,
I have never heard of a consumer getting sick
through an apple. I occasionally do hear from
consumers when they don't like the apples they
got.
Irrigation is the first practice
covered in the draft. We irrigate about 40
percent of our acres from wells and ponds. My
neighbors irrigate from a stream, from wells, from
ponds and when the stream gets low, they irrigate
from a swamp. Almost all of this water would not
meet qualifications you are asking for in your
draft. My pond is frequented from many forms of
wildlife and have fish and duck living within it.
Treating this will be a major expense, keeping
wildlife out of it would be an expense. I don't
know what, if anything, would be kept out by
covering the pond. Other growers use other
sources of water, among them Lake Ontario,
municipal water supplies and Erie Canal. And all
those sources of water are treated when they are
used for drinking water, but only the municipal
107
water supply will provide water to a grower that
is good.
Trickle irrigation use to eliminate
pathogens will be a great expense. Most packing
houses use water to empty the apple from the field
container to the packing line. We make up water
to that tank daily. We clean the tank once a
week, and change the water. Our water receives no
other treatment once it is in the tank. Some
packing houses do treat their water continuously,
between changing the water. Our weekly draining,
changing is about a three hour job, and to refill
the tank with water is about a ten hour process.
Frequent cleaning and refilling is certainly
possible, but I believe it would not be adequate
to give the water quality that is expected in this
draft I understand from those who do treat theirs.
Secondly, covered in the draft is
the use of manure. Fruit farms usually do not use
manure or sludge. Wildlife manure may be an
issue. I can think of no effective control
measure to keep all forms of wildlife out of the
Orchard.
The next draft covers sanitation.
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And hygiene field toilets and hand washing
facilities are required under OSHA regulations,
and are provided by most growers. My perception,,
however, is that they are not used by many field
workers, and supervisors have no means to require
their use. It is simply too easy for a field
worker to go behind a tree. Packing house workers
use toilets regularly, but may or may not wash
their hands. We do not monitor that. And
monitoring employee health, found most workers
will not report health problems unless they wanted
to miss work and associate income. I am not aware
of a solution to this problem, except for further
worker education. Our workers in the packing
house wear latex gloves when working with wet
apples. They are not required to. In addition,
federal and state inspectors handle fruit during
inspections, I never see them wearing gloves.
I will turn to the cleanliness of
our packing equipment. It is not modern
equipment, it is not equipment for washing down.
There is many exposed switches, many open, drip
proof motors, unsealed bearing belts, things that
can't tolerate water. There are many places where
109
leaves come direct contact, and are unacceptable,
but hard to clean, unless the machine is
disassembled. Which we don't do very often. We
use a large brushing machine to brush the apples
and that machine, the brushes on that machine are
damaged most of the time. The purpose of brushes
are to clean the apple and to dry apples, so that
would be a difficult thing to keep clean and to
keep sanitized. There is a large amount of dust
in the packing house. We use all new containers,
cardboard boxes, and cardboard boxes bring in an
awful lot of paper dust. It is just amazing how
that fowels up everything, as well as apples bring
in leaves and leaves bring in dust.
So no matter how frequently we
clean, the dust is always there. And as I said
before, when we clean, we don't clean inaccessible
places dust accumulates, ever.
Now, to trucking, trucks we hire are
clean, but that doesn't mean they are sanitized,
when the truck comes in not clean we send it out
to get clean. But, again, I say it is not
sanitized. Temperature control in trucks, it is
not a problem, trucks are all refrigerated, which
110
is something we require for the, to maintain the
quality of apples.
Tracability, we can trace apples
from our shipping dock when we ship them out back
to the orchard. They are all in bins and are
labeled when they come in, and those records are
kept right through the packing process. When our
customers get them, our customers are all chain
stores. I believe that most apples that are
displayed loose on the counter are not tracable
because they get apples from many suppliers. In
most cases they won't be able to identify ours
from other packages.
I guess I would like to add one more
thing. I think regulation like this will make it
difficult for the small farmer to continue. A
large farmer can afford to make some changes in
his operation, but the small farmer finds it more
and more difficult to compete today, to stay in
business because of the high cost of the new
equipment that is involved now in production.
Thank you.
THOMAS GARDINE: Thank you.
BEVERLY KENT: Next Rika Davis. Her
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commodity is fresh vegetables. She represents
Roads General Farm and also Finger Lakes Organic
Growers Cooperative.
RIKA DAVIS: Some of this is going
to sound familiar, some of it I think you heard
nothing like in this meeting.
At any rate I would like to start --
well, I will start by saying I'm pleased to be
here or to have been able to be here. As pretty
much everything else, as I would like to go on
from there to start discussing the process of
holding these meetings, which are supposed to
attract as much public comment as possible. I am
sure you have been hearing from lots of people
there was very poor notice, that there was very
poor publicity, the information I got from this
meeting I got in the middle of Thanksgiving Day
weekend, less than a week ago, as one flyer from
cooperative extension which was sent out by
Ontario Cooperative Extension. I never heard at
all, by the way, of the meeting on November 17th.
I don't expect I could have been there. If the
room was empty it was because you had no draft to
comment on, because nobody knew about the
112
meeting. There has not only not been enough
notice, there has been no availability of this
draft before the meeting except by way of the
internet. And I think the people who are used to
using this means of communication need to remember
there is a lot of people if this country who do
not yet have net access, who do not have a
computer for a wide variety of reasons. I wound
up spending three hours Monday night waiting for
the computer to download the document. I have
friends and farmers in the Mennonite community,
they do not use the internet. These should have
been announced in all the trade publications of
which there are quite a few, some of which do not
publish every three days, some of them publish
weekly, monthly. At least the ones that publish
weekly or monthly it should have been announced,
in addition with an address or phone number that
one could call or write to receive hard copy of
the report in the the mail sometime before the
meeting. If the United States government really
wants to have an open process and wants to have
public comments from a wide variety of growers in
this country, that is the way to do that. And
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this sort of thing is not the way to do that.
I will pass this on as much as
possible. I will note the deadline for written
comment is still too soon to get this copy out to
most of the written press versions because most of
them are past deadline for the next issue. Some
of them will not publish a next issue before the
deadline for written comment. We will get word
out best we can.
To go to the report itself, this is
currently very vague, it's full of
recommendations. We have been hearing repeatedly
this is not regulation. As if this is meant
solely to be information as to things that people
should pay attention to, it is not going to do any
harm. I don't think it's going to do a great deal
of help either, because I think that the cases in
which there really is serious contamination, as
long as we have this massive pressure to produce
all food as cheaply as possible, you are going to
have some people cutting corners. And if they
have got non-binding suggestions as to what they
can do that is going to cost money.
They also have massive pressure
114
coming from all levels, including federal
government, to produce food as cheaply as
possible, including as cheaply enough to compete
with the people producing it at wage levels of 50
cents an hour or in some cases less. You are
going to have a lot of trouble getting people to
take proper care with their fields with their
produce. You need to get people willing to pay
what the food is worth. If you start putting
these things in, either in by name or in an effect
as regulation. While still not being able to pay
what the food is worth, then you are going to have
more and more of it coming from places where the
labor force work for 50 cents an hour. I rather
doubt the inspection, that enough money is going
to be spent at the inspections at the borders to
give us anything like the clean food quality that
we are going to be expected to produce.
I would like to point out that there
has been a great deal of talk about the dairy
practices upstream and many diversified farms. The
dairy operation and the produce practices are on
the same farm. A great deal of produce in this
country is produced, and in my opinion should
115
continue to be produced, by small growers,
diversified growers, people who may, in some
cases, have 30 or 50 different vegetables crops, a
few acres of vegetables, who may have 20 sheep
over here and may or may not have a small dairy
operation. And any standards in terms of manure
handling -- it is one thing to tell a feed lot
maybe they are going to have to pasturize what
they are producing. But to tell somebody with 20
sheep they are going to run law for a pasurization
process, it is essentially not going to occur in
these operations.
We have and in fact been producing
clean healthy food in this country for many years
now with regulations designed for very large
operations and for operations with a limited
number of crops and with no livestock integrated
into the operation on the farm. And the studies
need to be done to determine whether food
contamination, in fact, is in fact a problem in
operations with chickens in the fields, with wheat
or geese in fields, and strawberries with deer
coming through the fields. I would be interested
with the way, with the sort of fence operation the
116
government thinks will keep mice out. We are
going to have animals in fields no matter what we
try to do about it. We have some control over
which ones and how many. We need to know how long
these contaminations exist in these situations.
This work needs to be done.
We hear a lot of having good science
in here, part of the good science is doing these
studies in these situations not only in a control
environment, in an otherwise steril patch. This
not only isn't a sterile world, it shouldn't be a
sterile world. It does not work as a sterile
world. Organic certified organizations working
with small diversified farm can supply useful
information here.
For instance, NOFA of which I am a
member, New York, does in fact have manure
handling standards addressing the issues brought
forth in the report as well as addressing other
issues, environmental issues. And a number of
other people pointed out that putting some of the
recommendations in this report into practice in
the wrong fashion, might in fact have massive
health repercussions elsewhere from environmental
117
damage. We do in fact have some regulations on
this.
We also have been doing a lot of
work in the last couple of years on what you have
been calling, I believe, traceback and what the
organic community, including the federal organic
people in Washington, have been calling an audit
trail, we are in the process of trying to work out
audit trail procedures that are suitable and not
impossibly burdensome for operations that may have
30 to 50 different crops in one field, many of
them being picked repeatedly over a period of time
over the season and going to several different
markets, including farmers markets, wholesale
operations and on the farm. We think its
possible, in some fashion, to do this.
I think before attempting to put in
any of what you are calling traceback regulations,
you need to investigate the work that has already
been done in this area.
In a little different direction, I'm
disturbed to find this report supporting the use
of sewage sludge. I understand the scope of this
report is microorganisms and not toxic metals.
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The version that I did get from the internet
stated three separate times sewage sludge is
beneficial material. And, well, I feel that the
microorganism problem actually can be dealt with
if properly treated. There are sufficient
concerns in terms of heavy metals and other toxin
build-ups that our area cooperative extension, for
instance, is extremely concerned about this. I
don't think it's the scope of this report to be
specifically recommending the use of such dubious
material. We need at some point to get human
waste back into the system also. We need to be
able to separate it from these other materials, we
don't seem to have that ability yet. When the
reports suggests that information derived from
handling sewer sludge in terms of lengths of time
and compost techniques to breakdown microbial
contamination is transferable to manures, probably
some of it is. The work needs to be done
separately on otherwise clean manuers. It is
quite possible that the results gotten from
materials that have other toxins in them such as
heavy metals may not be accurate when applied to
otherwise clean farm produced manures, the times
119
necessary and the temperatures necessary may or
may not turn out to be different.
Much of the problem that we have
been reading about in the newspapers and hearing
about at these meetings in terms of contaminated
foods has been cases in which people have gotten
ill over a wide number of states due to a problem
originating almost certainly in one packing house
or potentially on one farm or at one point in a
transfer line. If the government is really
serious about improving the safety of the food
supply in this area, the government should
consider also as much as is currently reasonably
feasible discouraging large centralized packing
houses and extremely small farms and unnecessarily
long distance shipping. Smaller suppliers should
be shipping over smaller areas. It is not only a
problem in one spot going to create a less of a
difficulty, it is going to be a lot easier to
trace it back, plus whichever additional set of
hands, every additional truck or shipper or other
process between the farm and the consumer adds
another potential source of contamination to try
to deal with this difficulty, which has a great
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deal to do with our food system. Solely by
descending upon the growers at the farm level and
not addressing the rest of this issue does not
seem to me be appropriate.
In terms of visiting farms, by the
way, this is a very good idea. Organic operations
often also actually take farm interns. If you are
really curious about what is happening at the
small farm, medium farm level, possibly somebody
in your office who is tired sitting in the office
could take a season internship at the farm, so as
to give a better understanding of what is going on
at our end.
I may well have other things to say
about this report had I had more time to look at
it and to consider some additional things that
came out at this point or others. I will probably
also be sending in written comments.
THOMAS GARDINE: Thank you.
BEVERLY KENT: Does anyone else have
any industry group presentations before we turn it
back over to the floor? I really appreciate
Maureen's comment about consumer education. It
was brought up earlier in the day, and I want to
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speak to that again. My name is Beverly Kent and
I am from the Buffalo FDA office and certainly we
are the closest FDA to this area. And to give you
an idea, we service the entire state of New York
except New York City and the five boroughs. We
spend a lot of time in consumer education. We
work very, very closely with the Cornell
Cooperative Extension Service to get our
information out to the State of New York, because
obviously it is a big state. And we have one
public affair specialist, her name is Diana
Monico, also Debbie Davy helps in the public
affairs area. If you know of consumer education
activities that are needed, please contact our
office and we will do whatever we can to get
information out to the consumers. Our office
phone number is (716) 551-4461, and again our
public affairs specialist is Diana Monico.
Tom, did you want to say anything about
education at all?
THOMAS GARDINE: Just to reiterate
what I indicated before, as part of this, there
will be education outreach on both the retail and
consumer levels, and hopefully we will be able to
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get some more details out, perhaps through
industry groups.
MAUREEN MARSHALL: Unfortunately I
had to come in late. I know some other people did
too. Can you reintroduce the front table for us
please?
BEVERLY KENT: I will start from the
last and go to the right. Rich Baldwin, he's the
acting director in the northeast region, and
Buffalo, New York is part of northeast region. It
encompasses all the northeast states. Then we
have Joe Ferrara, he's from New York State
Department of Agriculture and Markets. Mark
McLellan from Cornell University, Marvin Pritts
from Cornell University, and Tom Gardine from our
Center for Food Safety and Applied Nutrition. We
also have Joyce Salzman. She seemed to have
disappeared. She was one of the drafters of the
document.
We will go ahead and open it up to
questions on the floor. Please, again, go to the
mic, speak clearly, state your name, affiliation,
and please speak slowly. Thanks.
JOHN RUSSKIEWITZ: Thank you. I'm
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John Russkiewitz, I grow onions in Orange County,
not too far from New York City's doorstep. I'm
going to start out by overstating a point to make
a point perhaps. And that is as this country
imports more and more of its fresh fruits and
vegetables from overseas, the applicability of
your guidelines are going to become less and
less. In other words, what I'm getting at here,
what is going to be happening to our competitors
in overseas countries, my comments are coming from
the perspective of having spent six years in the
Middle East and two years in Vietnam during my
military career. So I've looked at a lot of
horrible stuff, I might add my tummy has had a
number of problems here and there, nothing like
these 24 hour bugs we run into here sometimes.
I'm going to move on. Not long ago
there was a radio program talking about washing
hands. And the comment was made that in the
country, in this country, this year 40 million
people will be getting sick because hands were not
properly washed. And not too long after that, I
was on the Thruway, I stopped for a pit stop, went
into the restroom, heard a toilet flush on my
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left, saw an employee of one of the fastfood
restaurants emerge, and notice he didn't wash.
And for the hell of it, I followed him back to his
workstation and I asked to see the manager. I
told him what happened and you know how things
happen, so much for that. You know, in the world
we have this situation where you have societies
where hot and cold running water is more the
exception than the rule. When you have situations
like that water gets carried, because it doesn't
come through pipes, because of that, or part and
parcel with that you might say, percapita
consumption of toilet paper is very low, and with
that of course people are not in the habit of
washing their hands, and this is where we are
getting more and more of our food product. Some
of these people are what should I dare say they
are walking timebombs loaded with pathogens and
parasites which could be deadly to some of us
whose stomachs aren't castiron.
I specifically remember when I was
in North Yemen, the Ambassador getting tapeworm.
The thinking was he ingested or breathed in the
dust, because we all lived in homes that had huts
125
around them, and it was not uncommon for people to
deficate near your wall. During the dry season
this stuff blew up and dried all over the place.
If anybody thinks I'm getting too gross, raise
your hand and I will stop.
In connection with this last week's
Packer had an article about the California
grower. I wish I could remember the commodity,
the announcement was this farm operation was
pulling out of California and they were going to
Mexico. Why were they going to Mexico? Somebody
said something about 50 cents a day. People will
work cheap if they don't have to pay for running
water. People work cheap if they don't have
electric bills to pay. You go and on.
This is basically what I wanted to
mention. The idea of what is going to be
happening overseas because, you know, my survival
is contingent upon a level playing field. Your
Freudian slip --
THOMAS GARDINE: I said exhaustion
slip.
JOHN RUZZKIEWITZ: I will show you
how that works, my brother, my son and I all have
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college educations, we practice IPM, we scout our
farm seven days a week from daylight to dark, but
we don't do it the Cornell IPM way. We don't hire
a scout who don't know the differences between a
cutworm injury and muskrat injury and comes only
twice a week, if you insist, instead of once a
week. I probably cannot sell my produce to
Wegmans because I don't practice the IPM, the
quote, unquote, prescribed way. That is all I
have to say. Thank you.
JOHN RAPPA: My name is John Rappa.
I'm with NRCS. My comments are mostly as a
citizen. Yes, in the past we have seen food
scares regarding apples, regarding hamburger,
regarding strawberries, and, yes, I agree with the
President's Initiative that food safety is an
important issue, and that we should do all we can
to insure that we all have good safe food to
consume.
But I think the initiative in a way
is a little limited because we are focusing in on
our farmers, we are focusing on the manufacturers,
and if you deal with farmers, you know that they
want to put a good product out on the market
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because it is important to them because it
reflects their income and the economics. I don't
think our manufacturers are out there to try to do
a bad job in processing food for us to consume.
I, at the same time, think it is important that
the initiative be expanded to include the
sellers. We have certain sellers in the area,
certain grocery stores that are trying to improve
their quality of products by working with farmers,
by using IPM practices so they can get the quality
food out to the consumer. So I think the sellers
should be part of the initiative rather than being
in the background, not in the foreground with the
other two partners.
I think it is also important to have
consumers as part of the initiative. It's
important how they handle the food, when they go
in the grocery stores, when they come home, how
they prepare it, things of that nature. They
should be a partner up front, rather than
background. So we all in the food chain are doing
what we can to insure that we all have safe food
and all stay healthy. Thank you.
STACY ZAWELL: I just wanted to
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point out something we discussed at national
advisory committee. This is under water section
in the introduction. There is a reference to a
Salmonella outbreak associated with unpasteurized
orange juice. It states although the causes of
contamination was not identified, one of the
growers supplying oranges to the implicated
processing irrigated with surface water that may
have been contaminated. This came up in the
discussion at the national advisory committee the
other day. In fact, the contamination, the
Salmonella was found on a number of critters that
were in the plant that should not have been in the
plant, such as frogs, lizards, in fact, that was
confirmed at that meeting. That will get changed
in the paper. I encourage you to increase the
accuracy of this document and have it reflect the
accuracy in this document.
UNIDENTIFIED SPEAKER: I realize the
guidelines are merely guidelines. I was wondering
if one of your connections with the FDA would look
into your crystal ball and tell us what sort of
discussion you're having and how this will be
communicated to our trading partners and how their
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growers will be reading your guidelines.
THOMAS GARDINE: I will respond,
because one of the reasons I wanted to get up and
speak and talk about the previous comments and
questions on the level playing field.
Two things to remember, what is
guidance for U.S. growers is indeed guidance for
our foreign trading partners. Nonetheless, as in
the U.S., if we become aware of a situation that
clearly poses a risk to the public health, we will
take action to prevent that product, be it fresh
produce, be it canned food, be it frozen food,
from reaching the consumer.
One of the aspects that we are
trying to work on right now internationally, we
have a mechanism in place through the ability of
states and USDA extension to evaluate farming
practices in the U.S. We have to find a way, as I
think I indicated on the earlier slides, to
evaluate and assess conditions in foreign
countries. Clearly, as in the U.S., where we hope
to work with extension service workers within the
states, work through them, excuse me, we hope in
foreign countries to work through the governments,
130
perhaps through their trade organizations,
nonetheless there will be a component, we hope and
expect of U.S. governments representatives
assessing conditions in the foreign countries, and
of course, if we come to a condition that clearly
represents a public health hazard, not just a
deviation from guidance, but something that is a
public health hazard, as we would in this country,
we would take steps to stop the introduction of
that product.
We are very concerned about the
level playing field issue. We intend to, within
the limits of our resources, to address that and
apply our evaluation techniques and our assistance
in terms of outreach and education at the same
level, internationally as domestically. Obviously
you have a follow-up question.
UNIDENTIFIED SPEAKER: I guess some
of us are not very impressed with the swiftness
our government acts upon issues. It takes a year
to resolve the tomato dumping issues.
THOMAS GARDINE: The tomato dumping
issue, you are now getting into a different realm
as opposed to public health. That is not the
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people in front of this room.
JEAN WARHOLIC: My name is Jean
Warholic. I'm with the New York State Vegetable
Growers. My memory is very long, and I remember
protection standards being a series of
guidelines. When my eye fell on a piece of
legislation it raised a red flag to me. Also I'm
going to read from something I put in our
newsletter. Senator Hollings in late October
proposed the Sanitary Food Transportation Act, it
would mean broad new enforcement in record keeping
authority by the FDA. This particular proposal,
again is a proposal, a bill, it doesn't mean it
will go anywhere. Here it is: The Highway and
Surface Transportation Safety Act of 1997 would
transfer the transportation, Safe Food
Transporatation Act enforcement authority from the
USDA and FDA from the DOT. The USDA would have
primary jurisdiction over the inspection and
regulation of meat, poultry and eggs with FDA
presiding over all food products including fruits
and vegetables. The DOT would retain jurisdiction
to enforce the transportation adulteration
provisions of the Food Drug and Cosmetic act.
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Transportation of food in violation of regulatory
standards prescribed by FDA would lead to the food
being deemed adulterated as a matter of law. The
amendment would provide FDA the authority to
compel the development of traceback and recall
systems for produce growers, shippers and others
in the distribution chain.
This makes me a little nervous. It
tells me there is some entities in Washington that
are making points or warming up real quickly to
the guidelines than we perhaps thought otherwise.
THOMAS GARDINE: Can I comment back
on that?
JEAN WARHOLIC: Please.
THOMAS GARDINE: Please note that
that was not administration legislation, it was
apparently introduced independently. We have no
control over this as an agency. I personally do
not know what position the Food and Drug
Administration is a taking on that bill. Please
remember we have 400 different congressmen, there
is no way any of us, except the people charged to
do so, can keep track of every bill presented that
might affect the Food and Drug Administration. As
133
you indicated, many of them go nowhere. Indeed we
do not know what will happen with this one piece
of legislation.
We have proposed the President's
Initiative, the president could propose it, it
doesn't mean congress will adopt it, nor does it
mean they will adopt it in the fall as the
administration submitted it. So what you are
saying is very interesting for the sake of this
audience so they don't think there is double
dealing on the part of the panel. That is not an
administration bill. I can honestly say I
personally did not know what the position is of
the FDA or administration has taken on that bill.
The other reason I got up, in
addition to talking about the issue of level
playing field was to stress we are aware of it,
let's remember everything we do must be in
conformance with the treaty obligation under GAT
and the World Trade Organization. This produce
safety initiative is the latest part of the
President's overall food safety initiative which
he announced earlier in this year. It is his call
to safety from farm to table. We are well aware
134
of the need to get retail involved in this through
training, education and outreach, and the need to
get the consumer involved in it. And we are doing
that. But for the purpose of this meeting, we did
not prepare, perhaps, and perhaps should have some
additional background on what we are doing in this
area. This is something that we may be able to
fix for the next round for the other planned
meetings, but I just want to assure you the
concept is safety from farm to table, that
includes retail, that includes the consumer. For
the purpose of this meeting, however, we are
talking about what we were doing in terms of
guidance for the grower.
BEVERLY KENT: Are there any other
comments?
TOM YAWMAN: My name is Tom Yawman.
I'm also on the faculty at the experiment
station. I want to talk on the manure
intervention program. I'm surprised that
particular piece is getting everybody's
attention. A lot has been said about the need for
science on getting good guidelines on that.
I would like to speak specifically
135
to some of the information we could use. I think
in vegetables we are particularly concerned about
the benefits of manure. One of the things that
makes healthy soil is by having microbial biomass
in the soil. The way you get bugs in the soil is
feed them organic material. The plan to add
manure is a very good one, and it should be
encouraged as much as possible. In doing so,
composting is the best. I think there is very
little disagreement if you can apply composted
manure, that is definitely the thing to do.
There are a couple limitations in
how this is done that have to do with science and
information. One is really the delivery of
information for farmers on compost. For dairymen
here, it's being done to a fairly large extent.
It still has limitations getting the information
to dairy farmers who could potentially compost
their manure, but are not doing so because they
can't figure out how it would be done.
The other is compost quality. This
something that has been addressed, sewage sludge
composting. I think some of the things that have
been brought up earlier, what are the time and
136
temperature criteria during the compost process
that will eliminate pathogens. I think biologic
science does not describe very well.
Sewage sludge composting, I think,
most importantly is how can you tell the compost
is going to support the growth of human
pathogens. It is really a matter of determining
what the safe composition of that is and whether
or not it will support human pathogen growth. It
is clearly a highly researchable subject.
I would like to go on to untreated
compost. Dale pointed out in his large highly
efficient operation composting is not going to
make sense. At the other end of spectrum, for a
very small dairy operation, and I am thinking
locally of certain Amish and Mennonite dairy
operations, they are not going to be composting,
period. It is not going to be happening, but they
are going to be using dairy manure on vegetables.
We need guidelines where there is
actual numbers in the guidelines that you
provide. And I have had a little bit of
experience in seeing how the guidelines get
implemented. I've served on the certification
137
board for NOFA New York. We certify most of the
organic vegetables farms in New York State. This
spring it became necessary to deal with the issue
of e. coli and manure application. The main piece
of information that the NOFA standards board had
to go on in deciding what to make the standard was
the brochure that Steve Reiner and his colleagues
put out. So 60 days was a pretty good number,
because a lot of people buy a lot of organic food
for safety issues 60 days before sewing was
standard. 60 days before sewing means the last
manure application before snow melt. If you want
to create minimum public health hazards, that is a
pretty good way to do it. The consequences of
trying to be safer from public health standpoint
made it worse for many, it violates other
standards of NOFA New York to apply manure at that
point.
What the guidelines needs to say on
this is conversion of untreated manure needs to be
applied in a way to mimimize contamination. That
is safe enough. Farmers can try to follow, they
need numbers so they can follow something on their
own farm. The specific numbers that they need and
138
what is researchable, how long does it take under
field conditions for human pathogens in untreated
manure to be degraded. We need to look at a
variety of field conditions. Clearly they will
disappear if you apply them in March when it is
below freezing and the snow melts and soil is
saturated with water. Then if you apply them in
August when it is dry and warm and very, very
metabiotically active in the soil, that is clearly
researchable.
We don't have any kind of data like
that. I think even if the guidines don't have
numbers, farmers will very much need those numbers
so they can do the right thing. Thank you very
much.
BRIAN CALDWELL: I'm Brian Caldwell
with Cooperative Extension here in New York
State. I cover vegetable and dairy production in
the four county area to the south. I guess my
take is going to be a little different on this.
The issue of wildlife in the fields was brought
up, it was spoken of in the way that one would
think the growers don't have much they can do
about that which is true. However, state and
139
regulatory agencies do have a lot they can do
about some of these issues, particularly with deer
and beaver. And those, I am not sure what the
real research connection is between deer and some
of these issues. I know that beaver have been a
majority and I guess if some of the
recommendations from this effort could be made to
some of the state agencies to facilitate lower
deer herd populations, and the only reason I
really came up to say I hope the growers will
listen to this is this is one of my pet issues,
anyways if they could be informed that there are
perhaps some human health issues related to having
deer presence and high deer herd levels and also
to make every effort to get rid of beavers in some
of the swamps.
THOMAS GARDINE: Do you guys in the
extension service talk to each other? This is
exactly, is this orchestrated, this is exactly
what one of your colleague's comment was at the
meeting in Grand Rapids, nature resource people
won't listen to us, maybe if we put a public
health aspect to this they will.
ANU RANGARAJAN: My name is Anu
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Rangarajan. One thing that, I was in looking
through the agriculture water section of this
document that I think we need to rethink about a
little bit more, and I will make written comments
to you, is the water testing. I alluded to some
of this earlier. We don't have any science behind
testing as to when to test, how to test and the
timing of the test. When the grower was to pull
the water test, the water they would be using
would be downstream, by the time they got the test
results back they probably will have a different
result from the same sample site. There is a lot
of issues about this ecosystem management that we
have to consider when dealing with issues of
agriculture water testing.
The other one there is reference
here to testing for e. coli. When we did a whole
sweep, a sweep for five organisims we got back a
positive Salmonella. Then the testing facility
had to send that out for typing. There is over
200 prevalent form of Salmonella. That gave us a
four week delay of whether or not this was a
concern. I'm not sure how we deal with this.
THOMAS GARDINE: But e. coli has a
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measure of potential fecal contamination. Is that
a viable approach or can you think of another
one? If you are going to give us written
comments, please think along those lines, not so
much as having to speciate the type of e. coli or
Salmonella or organisimis that might be there, e.
coli as a measure of fecal contamination of the
water supply. And what you are saying about, you
know, might be very true for river water, but is
it equally true for somebody who is drawing from a
pond, reservoir, a well and a swamp, I guess is
different to some extent, you know, but less true
than in a river.
So please, you know, think of it not
as having to speciate e. coli, find which pathogen
of e. coli is there, but look at it as fecal
contaminatin of the water supply and e. coli as an
appropriate rough estimate of fecal contamination
of water, just quick test that would be done to
give general idea of water quality.
UNIDENTIFIED SPEAKER: I think there
is some fluorescent tests that are pretty
instantaneous.
BEVERLY KENT: If someone has a
142
comment or question please proceed to the
microphone at this time.
STAN IWANICKI: My name is a Stan
Iwanicki. I'm with Agralink Foods. I have
several comments. Someone raised the issue before
about processing, requiring the guidelines to be
followed. As a processor that, to some extent
that could be true, and the reason it's true is
because our customers will likely demand it. It
is not something we would probably do on our own.
Our customers are people like Wegman's, the
supermarkets. We also supply bulk vegetables that
are frozen to people like Conagara, Nestle and
other processors for frozen foods. The problem we
run into is every time there is a food scare in
the newspaper, there is a buyer somewhere who has
the education, all their food safety education
from the popular crest, who finds something like
the guidelines in the public documents and decides
that that is a good idea to require as part of the
their specifications. So, therefore, it becomes a
de facto regulation or standard, and that is what
we run up against.
THOMAS GARDINE: You know, once
143
again, my question becomes what will they do, they
will come to you and say you should be in
compliance with the Good Agriculture Practice
document and you turn around to your grower and
what will you demand of them? How can this
document, which as I said appears to me to be
designed to be a self-evaluation assessment with
the intent and hope that growers where they see
defects address them. What can you do about the
lack of numbers there that you would require
growers to meet? Well, that is my second point.
STAN IWANICKI: As the document
stands right now there are no requirements and
there is nothing number wise, it is rather quite
vague. There is a demand, there is a lot of
research that is needed to be done. I think we
agree that that has to be done. We run into the
same issue on the Food Quality Protection Act.
There is a lot of research that needs to be done,
the problem is who is going to fund that
research.
I guess that is my question to you.
What type of research funding is behind this
program? Because what I have seen out of the
144
conferences that the research is needed. The
research is required, everybody says we need to do
it, yet it is not funded. How do we answer that
type of question.
THOMAS GARDINE: I don't know if
anyone from USDA wants to try to answer this too,
but I will point out that we are preparing for our
'99 budget. We believe we have a commitment for
funding for research. We are putting our research
proposals into that budget, and, you know, not
necessarily that we will do the research, but
maybe contract it out. As you said, we need
money. I will not be able to answer that question
until we see the '99 budget. That is the truth.
V.K. JUNAJI: I am V.K. Junaji, from
USDA Reasearch, Central Philadelphia. I am not
sure about the exact figures, we will be hiring at
least four to five permanent scientists and two
people are working in my project on this
assessment, and also at least two positions in the
Planning Center, they will be working on the
safety of vegetables and fruits. We did get a lot
of money as a result of all these outbreaks. We
will be filling up six person positions along with
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that that do all basic and applied research to
solve the food safety problems. This is all I
have to say.
STAN IWANICKI: The other comment I
have, I share the concern about the volume of food
production that's moving offshore. I think we
will see between the pressures from the Food
Quality Protection Act and the laws of some major
crop concessions to some other requirements that
may come about, perhaps with all this guidance,
and just the cost of farming these days. My
concern is before I retire, which is about ten
years from now, we may see significant portions of
our food produced offshore.
STACY ZAWELL: Stacy Zawell with
United Fresh Fruit and Vegetable Association. It
has come up a couple times today what, I would
like to do is help you understand from the
perspective from our members, what United's
members have been telling us, things that they are
afraid that the buyers are going to interpret at
their own will and ask in fact if somebody is
doing something, for instance, if there is a
mention that covering your reservoir will help, it
146
is up to the buyer to interpret that and say, you
know, he may come and say are you covering your
reservoir, what the public health impact covering
your reservoir is going to have.
The other thing is where it is
mentioned water quality should be graded for one
type of irrigation than another, it states drip
irrigation or methods where irrigation water
doesn't come in direct contact with produce may be
of less risk. The buyer can interpret that to say
everybody needs now to use, I want you to use drip
irrigatin because I question the water source in
that river, or I heard as a matter of that someone
found a pathogen in that water. That is good
enough for them to interpret and say you should
use drip, and you will go out of the business.
The other thing is produce to wash
water temperature differential. If that is used
and somebody says do you have this ten degree
temperature differential and you don't, forget it,
you are forgetting all of the other parameters
that dictate wash water temperature is there.
Instead of focusing on this major number, let's
focus on making sure the wash water is clean. The
147
issue is, while research is being done on apples,
Tom, what about all the other commodities it
hasn't been applied. So I think we need to insure
that the wash water is clean. And there are a
number of other examples that some of our members
have stated to us they have concern being
interpreted by a buyer and other people they
supply.
THOMAS GARDINE: And some time
during these other grassroot meetings we will hear
about this and other ones. We do want a list of
them please.
JOHN RAPPA: John Rapa. Just to
echo some of the concerns that have been expressed
with foreign foods coming into this country. If
the same food item was before me, one was marked
USA, one was marked some foreign country, I would
be selecting what was grown in USA rather than the
foreign food item, because of the, you hear many
stories regarding foreign countries do not follow
the same procedures we do as growing our food
substance. That kind of scares me that they are
doing things completely different than what we
do. They don't use IPM practices as much as we
148
do, they don't follow herbicide recommendations or
pesticide recommendations. You hear stories, you
read about them. I think that is a major concern
that we are going to be importing items into this
country. We need to look into what they are doing
so we could feel safe about it.
BEVERLY KENT: Does anyone else have
any other comments or questions?
Okay, I would certainly like to
thank you all, a sincere thank you all for
attending this grassroots meeting today. I think
it was a great opportunity for everyone, certainly
at the table, for everyone in the audience to hear
what others had to say. Certainly we appreciate
your comments. I think there was some really good
points made today.
UNIDENTIFIED SPEAKER: Can you give
the date for the cutoff or the written comments?
BEVERLY KENT: December 19th. You
should get a copy of the federal register notice.
If you haven't gotten a copy of that, it will be
in there.
Are there any questions from the
head table, comments?
149
Okay. Once, again, thanks a lot and
have a safe trip home.
150
C E R T I F I C A T I O N
I hereby certify that the proceedings
and evidence are contained fully and accurately in
the notes taken by me on the above cause and that
this is a correct transcript of the same to the
best of my ability.
___________________________________
MICHAEL D. MINNIES
VERBATIM COURT REPORTING SERVICE, INC.
402 WEST CHURCH STREET
ELMIRA, NEW YORK 14901
800-368-3302
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