LETTER
REGARDING JUICE SAFTEY 1997
February
3, 1997
Dr.
Fred Shank
Director, Center for Food Safety and Applied Nutrition
Food and Drug Administration
200 C Street, SW
Washington, DC 20204
Dear
Dr. Shank:
My
name is Laurie Girand, and I am sending in written comments
addressing your Public Meeting on the Safety of Fresh Juices
held on December 16 and 17th as a concerned parent, as a member
of the juice consuming public, and as a businessperson. I
have the dubious distinction of being the mother of a three
year old who developed HUS complications after drinking Odwalla
apple juice. I will attempt to address why E. coli has brought
about such public concern, why consumer perception must play
a role in the FDA's planning, and what I believe the FDA needs
to do about juice contamination.
E.
Coli O157:H7 Is Not Just A Little Flu
Sorely
missing from the December Public Meeting on the Safety of
Fresh Juices was an accurate description of the reasons why
E. coli contamination is considered unusually hazardous. From
the meeting transcripts, it is apparent that many participants
are completely unaware about the effects of E. coli 0157:H7
on seniors, children and the immune impaired. In point of
fact, the participants weave back and forth in testimony on
the topic of how they test for E. coli, making little distinction
between the deadly killer, unpalatable levels of coliform
bacteria of indeterminate origin, and "helper" bacteria
that assist people and animals digest food. I therefore will
refer to E. coli O157:H7 as "O157" throughout my
comments.
When
we speak about the hazards of O157, we are not just speaking
about a little flu, or a bout of Montezuma's revenge. We are
speaking about near-constant diarrhea that, when not just
tinged with blood, gushes bright red and is often coupled
with severe stomach cramps that have been likened to labor
pains. We are speaking about a poison that, once the intestine
is penetrated, spreads through the body like rattlesnake venom.
At first, red blood cells and individual platelet counts drop,
within a couple of days leaving the victim vulnerable to brain
hemorrhaging and uncontrolled bleeding. The patient's pallor
grows ashen, his gums gray. Typically, blood transfusions
are used to provide more red blood cells; yet, at times these,
too, are quickly destroyed by the O157 toxin. Platelets disappear
because they are forming clots and begin to travel through
the blood stream, blocking capillaries in the kidneys, the
middle layer of the heart and the brain. As the kidneys cease
to function, the body swells with excess waste fluids. Constricting
hospital bracelets must be cut off, and as the uremic poisoning
continues, dialysis must begin. Dialysis is used because as
of today there is no antidote, no antibiotic, no "cure"
for what is killing the patient. The expectation is that some
of the poisons may be siphoned off, and therefore the impact
might be reduced. In the meantime, however, it is possible
for the patient to go blind, have strokes, go into a coma,
suffer heart failure or become partially paralyzed. At any
point along the way, the victim can easily die even if he/she
receives proper treatment.
And
unfortunately, while we heard or read testimony from the eminent
Dr. Tarr in Washington, very few pediatricians or physicians
are prepared to even run the tests to diagnose O157. During
the latest juice epidemic, two children were turned away from
emergency rooms that deemed them not sick enough; another
child's stool was not cultured because it was deemed not bloody
enough; and at least one child was specifically prescribed
contraindicated medicines. So, worse than the fact that there
is no "cure" for an O157 patient is the very real
fact that many real cases are undetected, misdiagnosed or
mistreated until they are well into advanced stages. If your
child or parent is infected by O157, you cannot count on your
medical professional to identify it in a timely fashion. In
short, this truly vicious disease leaves the most defenseless
among us fighting for their lives. And if victims survive
the initial bout, they suffer the life sentence of a host
of potential significant complications, including the possibility
of having their kidneys fail before they reach adulthood.
Another
key point is that O157 bacteria were recently determined by
Thomas Cebula of the FDA to be mutating at a far faster rate
than was previously suspected. Every year, they are evolving
to survive under harsher and harsher conditions, and according
to Stanford biology Professor Philip Hanawalt, "Something
you develop to treat them, to kill them, is not going to be
effective."1 The result is that processes that were adequate
for producing safe juice 20 years ago, or as several participants
were fond of mentioning in the history of cider, 200 or 300
years ago, can no longer be presumed safe. The worst thing
the FDA, growers, producers and distributors can do is drive
full speed ahead while looking in the rear view mirror.
As
mentioned previously, the purpose of the meeting and comments
is to share what we have learned, and I would summarize my
understanding as the following:
- The
FDA has known for over five years that apple juice can be
a source of O157 contamination, but has done little to directly
inform consumers of the potential for epidemics aside from
issuing infrequent press statements.
- As
tree-borne fruit, apples should be one of the safest fruit
for juice production. They are not grown IN the ground,
like carrots. They are not grown ON the ground like strawberries
or melons. Yet, we have had repeated epidemics with apple
juice/cider as a source.
- The
sources of potential contamination by O157 in the juicing
process, whether from dropped fruit, wild animals, nonpotable
irrigation water, floating fruit in contaminated water,
unclean packing crates, human hands, or otherwise, are so
diverse that it is unclear whether anyone can develop a
completely safe fresh juice process. Even the source of
Odwalla's contamination is still undetermined. Yet, in the
face of the preponderance of evidence, many growers and
producers believe that contamination "can't" happen
to them.
- Worse,
there is no evidence that current production processes reduce
potential for O157 contamination. There is no data that
leaving cow manure out in a field for 30, 60 or 90 days
or even six months or a year can kills O157, though the
Certified Organic Farmers would have you believe otherwise.[2
]There is no data that O157 cannot penetrate the peel of
an apple, or an orange for that matter. There is no data
to support that washing and brushing fruit does anything
to eliminate O157.
- Even
after production of large batches of juice, current food
testing is unable to detect small, lethal quantities of
O157 because it can take as few as 1 to 10 bacteria to cause
illness. Hence, there is no way to test with certainty that
unsterilized juices are safe.
- At
present, consumers are not adequately informed of the risk
of contamination, and no one has checked along the way to
be sure that the product they are buying is safe. If they
buy fresh produce, they are told to wash it; yet, there
is no data that washing fresh produce, either with bleach
or detergent can eliminate O157 contamination on a piece
of fruit. As a result, consumers are defenseless in the
face of unsterilized juices and produce. As long as the
consumer is treated like a mushroom and kept in the dark,
uninformed demand for contaminated product will continue
to exist.
- The
current rates of infection are so grossly unrecognized and
underreported that no one, not even the Center for Disease
Control and Prevention, can presently state accurately how
often people are being sickened or dying from this disease.
Nor can anyone identify all the produce-related sources
of O157 poisoning. No fruit or vegetable can yet be ruled
out as a point of possible origin.
In
the context of underreporting, I would ask that, in the spirit
of openness and public interest of this meeting, the FDA and
Odwalla describe exactly how many "servings" of
contaminated apple juice were distributed across Colorado,
Washington, California and British Columbia. Having spoken
with the California State Epidemiologist Sara Cody, I know
that both the FDA and Odwalla are in possession of this information.
While participants invited to the December meeting are applauding
the recall efforts, consumers deserve to be provided with
an accurate assessment of just exactly how many people were
potentially exposed to this deadly killer in addition to the
number that was actually diagnosed. It is this precisely this
type of information, which the FDA keeps closely guarded,
that would begin to give consumers a sense of the magnitude
of the risk they face.
The
Impact of Consumer Behavior on Fresh Juice Epidemics
Having
addressed the details of O157 in particular, I would like
to share with you my insight into customers as a marketing
strategist, which is my business. To understand how to prevent
an epidemic from happening, you need to be aware of the consumer
behavior that led people to feed contaminated apple juice
to their children; yet, your hearing testimony is woefully
lacking in consumer research. What makes the most recent epidemic
different from previous 0157 outbreaks is that there is a
clear misperception amongst consumers that fresh fruit and
vegetables are always good for you. The government actually
promotes fruit and vegetables to parents, telling them that
they are an important component of a young child's diet. Parents
think when they feed their children "fresh" products
they are doing them a nutritional favor. .. that's why the
economics of fresh juice supports premium pricing and high
margins. Consumers currently buy the marketing concept that
"fresh is better" with their dollars. They show
that through the growth of the fresh produce-related and "natural"
foods industries.
Are
consumers wrong to believe that fresh is better? No, if uncooked
fruit and vegetables are free of harmful organisms and pesticides,
they can be better for you because vitamins, minerals, colors
and flavors have not been lost in a cooking process. The organic
food industry has burgeoned in part by making the distinction
about pesticides, but no one breathes a word to consumers
about mutant bacteria in fresh produce. Instead, the consumer
misperception that fresh is always better is reinforced by
hundreds of millions of dollars of marketing poured
every year into the words "Fresh," "Natural,"
and "Organic" by produce producers, packagers, distributors
and restaurants. This "fresh=healthy=better" concept
is promoted aggressively by companies that charge premium
prices for the benefit of providing supposedly healthier alternatives.
These companies were not necessarily invited to the FDA meeting,
but include grocery stores such as Whole Foods Markets; salad
bar restaurants such as Fresh Choice; and the local juice
bars on the corner, such as Nectar's. To give you a sense
of just how far this "fresh=better" connotation
goes, prior to the outbreak, one of Odwalla's promotional
slogans was "Live Juice."
In
addition, the following combination of consumer and producer
trends exacerbate the likelihood of food borne epidemics in
the 1990's and the next century:
- increasing
trends toward eating at restaurants and take-out food
- increasing
demand for salad-bar restaurants
- increasing
trends toward eating "healthy" foods
- the
government promoting vegetables and fruits over other parts
of the
- food
pyramid
- improvements
in transportation and distribution of fresh produce products
- improvements
that enable conveniently prepackaged fresh foods
These
trends will not go away by merely pasteurizing juices. There
is too much economic interest at stake.
Beyond
addressing juice processing mechanics, the FDA must address
this gulf between consumer perception--"fresh is always
better"--and reality--"our food supply is contaminated
with organisms that can kill small children and seniors."
Otherwise, the multimillion dollar war of perception will
continue to take lives.
To
give you a sense of the determination of fresh juice producers,
after Odwalla pulled its stock from shelves, other smaller,
unpasteurized competitors took advantage of the situation
by getting stocked in Odwalla's cases in grocery stores. Clearly,
if the demand continued to exist, consumers do not understand
what the FDA knows: contamination really is a fresh produce
problem, not just an Odwalla apple juice problem. As a consumer,
I find it frightening that many fresh juice growers do not
seem to recognize the gravity of this situation. As a businessperson,
I know their willingness to look the other way is basic business.
Apple juice is not the second largest juice industry in the
country because adults are drinking it. It is the second largest
juice industry because children, the chief potential victims
of O157, are the chief consumers of apple juice.
I'd
like to take you a little further into the mind of an educated
consumer, and I'll use myself for the moment. When I was pregnant
with my daughter, I neither drank nor smoked nor consumed
caffeinated products. My infant was breastfed for seven months.
When she began to eat solids, I read labels to determine relevant
quantities of salt, sugar and other additives and preservatives.
She ate Earth's Best baby food because it had the highest
nutritional content and the fewest additives, and I balanced
her diet by verifying that the mix of food she received included
appropriate quantities of vitamins and minerals. I fed her
no juice or honey until after she was two years old. When
she started nursery school this last September, she went to
school twice a week with Odwalla carrot juice and three times
a week with milk. I virtually never fed her apple juice because
it is considered remarkably low in nutrition. Do I read labels
for pleasure? No, I follow them because they are intended
to inform me of the tradeoffs I make in purchasing and feeding
decisions.
Suffice
it to say that I would not be writing to you today if the
FDA had adequately informed the marketplace and consumers
after the first, second or third poisonings from fresh juice.
In point of fact, the FDA needs to know that by waiting this
incredibly conservative five years, it shares responsibility
for the 12 identified 0157 victims that now face a lifetime
of possible kidney failure from Odwalla juice. It is time
for action.
And
as a consumer, I will take a stand that might surprise you:
uniform, mandatory pasteurization is not the solution. It
fails to be a solution because it is a simpleminded, stop-gap
measure that allows everyone to bury the contamination issue
so that consumers won't need to know that food borne illness
is a significant problem in this country and that children
and seniors are dying from it. It needlessly puts many small
growers out of business when there is still adult demand for
their products. It fails to take into account restaurants,
hotels and juice bars. It ignores the issue of fresh produce.
And, fundamentally, it denies everyone the right to informed
choice.
Thus,
from my experience, labeling is a single, cost-effective answer
on how to inform parents, seniors and the immune impaired
so that they know these products are unsafe. When consumers
are educated about hazards, they can make up their own minds...they
can actually choose to vote with their dollars. When everyone
knows the same information, market forces go to work. If consumers
were educated about hazards in produce, some would demand
that food be grown under sterilized conditions, and they would
pay a premium for that safety. Companies would develop two
product lines, one that was safe for children, the elderly
and the immune-impaired and one that was riskier but might
taste better. Industry research money would pour into improving
nutritional qualities and safety simultaneously.
Juice
Safety Recommendations
My
juice safety recommendations cover three areas: comprehensive
labeling of juice and produce, HACCP, and traceback.
Labeling.
First, for juices there should be two labels. Consumers
need a simple, umbrella term such as "sterilized,"
not "pasteurized" for three reasons:
- To
simplify and identify the benefit that consumers are really
seeking; we should not assume that all consumers know
that "pasteurized" means "sterile;"
- To
recognize the possibilities that other methods besides
pasteurization might be equally effective at killing organisms;
- To
avoid creating confusion about the validity of different
sterilization processes.
Consumers
do not care which sterilization process is used if the end
products are sterile and share nearly identical results
without hazardous side effects.
The
two labels would be as follows: "STERILE: This product
has been sterilized and is believed to be safe for consumption
by children, seniors and the immune-impaired." The
second label is "UNSTERILE: This product has not been
sterilized and may contain organisms that can cause illness
and death in children, seniors and the immune impaired."
The operative terms here include "safe," "death,"
"organisms," and identification of the consumer
at risk.
It
would NOT be appropriate to use just one label or the other.
If only the STERILE label were used, consumers would not
be educated or warned about hazards appropriately. If only
the UNSTERILE label were used, consumers would be challenged
to identify safe products. Consumers must be able to clearly
distinguish between safe and unsafe products; otherwise,
consumers will not be able to make informed decisions and
send clear financial messages to producers.
It
is critical that the FDA not merely address bottled juices
but plug all the holes in this system. Warning signage must
also be prominently displayed at any place selling or distributing
fresh juice, including specifically restaurants, grocery
stores, coffee shops, and juice bars. The signage would
state: "This facility sells fresh juice that has not
been sterilized and may contain organisms that can cause
illness and death in children, seniors, and the immune impaired."
This
labeling must be applied equally across all juices. It is
not appropriate to exempt orange juice just because today
it hasn't proven to be a source of many epidemics or because
it is more acidic or because oranges have a peel. Until
there is data that proves that a juice is truly unique and
harbors natural antibiotics, all fresh juices should be
suspect for microbe contamination. As you begin exempting
each juice, you make an incorrect assumption; until the
sources of all microbial contamination are clearly identified
and eliminated, no unsterilized juice can be deemed safe.
I
would go a step beyond the scope of this Public Meeting
and insist that the FDA address fresh produce as well. Some
of the sterilization processes proposed for juice would
work equally well on fresh produce and fresh produce products.
When included in salad bars, pot-lucks or salads-in-a-bag,
a single head of contaminated lettuce can have devastating
epidemic effects. All fresh produce and fresh produce products
must also be labeled as either sterilized or unsterilized.
The "Sterile" and "Unsterile" labels
should be identified with a small symbol that would be used
on such products. Strawberries have plastic wrapping packaging.
Apples have stickers. Any fruit or vegetable that did not
support labeling would be placed in an appropriate section
of a grocery store with the notice above it.
Labeling
will need to be backed up with science. The FDA must be
responsible for declaring that a sterilization process,
whether irradiation, high pressure, flash pasteurization
or additives, is adequate. At what temperature and length
of time does flash pasteurization fail? Annually, the FDA
will need to take test samples of the product, contaminate
them with the latest strains of O157, and verify
that the current sterilization techniques do actually work.
Likewise, good science says that the worst possible thing
that we can do is to use a process that somehow eliminates
some but not all of the microbe, as implied by some meeting
participants, as this will ensure that 0157 is able to mutate
to withstand the process. We must know with certainty that
these processes continue to work over time.
HACCP.
The more I have learned about HACCP guidelines, the more
I believe that they are business common sense, and that
the growers and producers of juice, produce and product
products should not be exempt from paying attention to contaminants.
I believe these practices should be the norm in the industry
and will help identify potential sources of epidemics. However,
alone in the face of highly undetectable O157, HACCP is
by itself insufficient to protect consumers.
Traceback
and Penalties. Lastly, I believe that the only way
to guarantee that growers institute safe practices is by
providing thorough traceback. The primary reason that many
growers and packing houses are not accepting responsibility
for food borne illness is that the current levels of traceback
leave them completely off the hook. While companies like
Starbucks, Odwalla and Safeway suffer from the full ramifications
of personal injury law, the growers and packing houses know
that if victims cannot identify them, they cannot be held
responsible. Similarly, they deserve to be quickly exonerated
if they are not to blame.
What
are the penalties for causing an epidemic that kills and
maims people? What are the disincentives to keep this from
happening again? The government does nothing but issue warnings
and call meetings. If the government does not institute
substantial financial penalties on behalf of victims of
food borne illness epidemics, the least the FDA can do is
provide them with the source. Traceback should not be a
mystery requiring investigation of 30+ orchards; it should
support identification of the handful of potential sources
immediately. If the wine industry can tell you which vineyards
grow the grapes in their bottles, the juice companies can
do the same. Labeling that clearly identified produce sources
would also provide U.S. produce growers with the ability
to differentiate their produce and fresh produce products
from foreign sources.
In
Conclusion
One
question was raised repeatedly during the meeting, "What
is an appropriate level of safety?" As a parent and a
consumer, I have to tell you: that's not your decision. My
husband and I make the decisions about our children, not you.
We chose when to conceive them. We choose their pediatricians.
We choose the community in which they live. We determine when
they are old enough to cross the street by themselves. We
decide whether they receive transfusions and surgery. And
we will be the first people in line if and when my daughter
ever needs a kidney, not you. I thank you for your willingness
to sacrifice my children's lives and health for the best interest
of your businesses, but I want 100% safety in the food I purchase
at grocery stores and restaurants, and now that I am an educated
consumer, I expect to be offered a choice between food that
is safe and food that is not.
Setting
aside your feelings as experts or business people, I would
now like to suggest a scenario that will help you share the
perspective of parents of 0157 victims. Imagine that your
child was abused by someone, almost to the point of death.
Yet, the abuser wanders around free. In fact, you unwittingly
introduced that person to your child, and every day you have
to invite that person to a meal for the rest of your life.
Even worse, you know the person is invited frequently into
the homes of other children. There are no Megan's Laws that
will help publicize this killer. In fact, there is no money
spent on educating parents to save their children. We ask
that the FDA take the extraordinary steps to ensure that parents
can at least identify the potential presence of 0157 and prevent
it from revisiting our children. Only you have the power to
save lives.
Signed,
Laurie
Girand
Signed,
Nancy
Donley
President,
S.T.O.P--Safe Tables Our Priority
- [1]
Puzzanghera, Jim; "Why E. coli is so hard to corral;
Bacteria change genetic form often, eluding control efforts,"
San Jose Mercury News; November 15, 1996, page 1.
- [2]
Solovitch, Sara, "Look for the certified organic label,"
San Jose Mercury News; December 4, 1996, p. 2e.
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