FOOD
SAFETY STRATEGY (part 2)
February
8, 1999
Dockets Management Branch (HFA-305)
Food and Drug Administration
12420 Parklawn Drive,
Room 1-23
Rockville, MD 20857
Re:
Docket No. 97N-0074
Safe Tables Our Priority is a nonprofit, grassroots
organization consisting of victims of foodborne illness, family,
friends and concerned individuals who recognize the threat
pathogens pose in the U.S. food supply. S.T.O.P.'s mission
is to prevent unnecessary illness and loss of life from pathogenic
foodborne illness. We count among our members victims of E.
coli O157:H7 contaminated meat, lettuce and apple juice;
hepatitis A contaminated strawberries; Vibrio vulnificus
in oysters; Salmonella contaminated poultry and eggs;
and Campylobacter contaminated poultry. In all of these
cases, the dangers of potentially contaminated products were
known to government. And in all of these cases, inadequate
efforts by government to warn consumers failed to protect
them from life threatening illnesses.
We are submitting these comments today as
an addendum to previous public comments we have submitted
on the topic of the Food Safety Strategy and to conversations
we have had with FDA. S.T.O.P. is particularly interested
in FDA standardizing its approach to food safety with an eye
toward making the organization more efficient and effective.
Our comments today are organized as follows:
I. The Need for a Standardized Definition
of At-Risk Groups
A. Expanded Descriptions of Existing Acknowledged
At-Risk Groups
B. Acknowledgment of Link Between Listeria
and Other Fecal-Based Pathogens
II. The Need for Standardized Labeling as
A Form of Notification
III. The Need for HACCP Back to the Seed and
Soil
IV. The Need for a Standardized Approach to
Hazardous Foods
V. The Need for Standardized Messages, Appropriate
to the Hazard
I. The Need for A Standardized Definition
of At-Risk Groups
Under FDA's current system, every time a safety
issue arises in a different food, FDA reevaluates who qualifies
as "at-risk." To increase overall agency efficiency,
saving both time and money, S.T.O.P. strongly advises that
FDA develop, in conjunction with USDA and the CDC, a standardized
position on which people are considered at-risk from different
foodborne illnesses and hence from different foods. Under
the current system, every time a specific food falls under
FDA scrutiny, FDA examines the at-risk group question over
again (for example, first for juice, next for alfalfa sprouts).
In reality, certain groups of consumers are at-risk for particular
pathogens regardless of the type of food in which the microbes
are found. Standardized, expanded definitions of the at-risk
groups would enable FDA to more efficiently implement labeling
rules and to more effectively help consumers identify whether
or not they fall into these categories through FDA's public
relations and targeted marketing efforts. We believe that
these types of decisions are too important to be relegated
to the back seat of every food safety issue.
A. Expanded Descriptions of Existing
Acknowledged At-Risk Groups
Who should be concerned about oysters? Who
should be concerned about unpasteurized juices? While it might
be sufficient to say "immune impaired" on a label,
consumers need a medically and scientifically determined definition
as to whether they fall into each category. S.T.O.P. has pointed
out that people on antibiotics and antacids are more at-risk
than the general population, though they would not necessarily
characterize themselves as "immune impaired." Antibiotics
can wipe out healthy bacteria in the gut that compete with
harmful bacteria and otherwise keep them from growing out
of control. Antacids reduce the acidity of the stomach, allowing
less acid resistant organisms to pass through to the gut.
S.T.O.P. recently voiced objections to the term "elderly"
over the term "seniors" in labeling language due
to the concern that consumers would not understand whether
or not they qualified as elderly. We would like to see FDA/CDC
publish an expanded definition for added clarity. These matters
are of life threatening urgency.
B. Acknowledgment of Link Between Listeria
and Other Fecal-Based Pathogens
Of particular concern has been FDA's reluctance
to include "pregnant women" as an "at-risk
group" for unpasteurized juices... or for other foods
known to harbor fecal contamination.
In the juice labeling final rule, FDA referred
to the CAST report which described the complications of Listeria
monocytogenes as "miscarriage." This term is
inaccurate and underrates the severity of the consequences
of a Listeria infection. According to Webster's Third
New International Dictionary the definition is: "a:
expulsion of a human fetus before it is viable esp. between
the 12th and 28th weeks of gestation --compare ABORTION, PREMATURE
DELIVERY b: abortion esp. when due to natural causes."
Babies that are quite viable can be terminated in utero by
a Listeria infection up to the point when they are
considered full term. Babies that are born either prematurely
or at term with a Listeria infection can develop meningitis.
Listeria is known to have a high mortality rate.
Particularly insidious about a Listeria
infection is the fact that: "Asymptomatic fecal carriage
is common in humans (up to 10%)...". According
to the USDA, not all doctors know the symptoms even when they
do appear. Recent USDA-related recalls have
demonstrated that when government enforces its zero tolerance
for Listeria, vast quantities of food are found to
be contaminated with the organism. These factors, combined
with all the standard issues surrounding underreporting of
foodborne illness, suggest that there is high probability
that all Listeria-related illness and fetal demise
are grossly underreported.
When an FDA-overseen food has been linked
to multiple types (e.g. E. coli O157:H7 and Salmonella)
of feces-sourced contamination, it has also been connected
to Listeria monocytogenes. The two produce-related
foods which have caused FDA to take the greatest action in
recent years are alfalfa sprouts and unpasteurized juices.
Both have experienced repeated outbreaks of Salmonella
and E. coli O157:H7. FDA investigations in 1997-1998
of unpasteurized apple juice found a 14% generic E. coli
or fecal coliform contamination rate in samples tested.
Tests by USDA and the Florida Department of Agriculture
conducted between 1996 and 1998 have yielded a generic fecal
contamination rate of 4% of samples or 5% of firms in unpasteurized
citrus juice.
In both unpasteurized juices and alfalfa sprouts,
Listeria has been found as well. Alfalfa sprouts were
recalled in September of 1998 for Listeria contamination.
It has been reported that Listeria was found in
Odwalla-brand juice by Odwalla quality assurance employees
prior to that company's unpasteurized apple juice outbreak/recall.
The San Jose Mercury News article which describes the
finding of Listeria in Odwalla's unpasteurized juices,
indicates that tests found Listeria "in about
five samples of apple juice and two in orange juice."
They also found evidence that Listeria was on the fruit.
Based on FDA's investigation of the Odwalla outbreak, it is
possible that FDA may have further data on this particular
incident. The same article indicates:
"Dr. Douglas L. Archer, an Odwalla
consultant and former deputy director of the FDA's Center
for Food Safety and Applied Nutrition, said that some listeria
is likely to be found in any juice if enough of it is tested."
We presume because the article focused on
unpasteurized juices that his comment is directed at insufficiently
pasteurized juices. This combination of opinion and data suggests
that Listeria will be found in unpasteurized juices
if only FDA would test for it.
FDA's argument against including pregnant
women in that at-risk groups for unpasteurized juice warnings
labels noted:
"FDA acknowledges that the CAST report
noted that the immune system of a pregnant woman is altered
to some extent compared to that of a non-pregnant woman.
In looking at the populations at greatest risk from foodborne
pathogens, CAST identified pregnant women as a group at
risk from L. monocytogenes, a widely distributed pathogen
that has been associated with miscarriages. Nonetheless,
there is not evidence that pregnant women or their fetuses
are at any greater risk of serious illness from the foodborne
pathogens associated with juices than the general population.
The agency notes that Listeria has not been identified in
the documented cases of illness associated with consumption
of untreated juices."
In trying to understand FDA's response, S.T.O.P.
asked Dr. Larry Pickering of the Center for Pediatric Research
in Norfolk, VA whether pregnant women are considered more
susceptible to diarrheal illnesses, his area of specialty.
Dr. Pickering, who is a member of the infectious disease committee
at the American Academy of Pediatrics, responded with the
following:
"Pregnant women are considered to be
somewhat immune compromised during pregnancy. With regard
to foodborne associated illness, maternal infection with
several organisms has been associated with abortion, preterm
delivery and other obstretic complications. Organisms of
concern include Listeria, Campylobacter, Salmonella, enterohemorrhagic
E. coli, Yersinia and Brucella to name a few."
Pregnant women can and should be considered
more susceptible to some foodborne illnesses than the general
population.
With regards to Listeria in particular,
we believe that FDA must seriously consider the probability
of Listeria contamination in unpasteurized juice. According
to the Control of Communicable Diseases Manual, asymptomatic
fecal carriage of Listeria is also common in animals.
Hence, E. coli O157:H7, Salmonella and Listeria
all can share a common originating point of contamination:
animal feces. Listeria is also considered more heat
resistant than E. coli O157:H7 and is better able to
withstand environmental stresses. Therefore, where
multiple fecal pathogens have been found in foods due to insufficient
sanitation or killsteps, Listeria can survive as well
and follow the same route into the final food product.
At present, there are NO materials published
by the CDC or FDA that alert pregnant women to the risks of
contamination in unpasteurized juices. S.T.O.P. does not believe
that FDA's public health risk assessment requires that people's
illnesses and deaths must be genetically fingerprinted to
a specific food before FDA can take action. S.T.O.P. implores
the FDA to consider pregnant women as a separate at-risk group
for foods that show repeated fecal contamination and urgently
requests that FDA add "pregnant women" to the at-risk
groups listed in warning labels for unpasteurized juices.
II. The Need for Standardized Labeling
as A Form of Notification
In its combination of juice labeling and juice
HACCP requirements, FDA has unevenly and inadequately warned
consumers of unpasteurized juices by only addressing packaged
products. Restaurants, juice bars, and small businesses have
been exempted from the Proposed Rule.
S.T.O.P. points out that as other repeatedly
contaminated foods, particularly produce-related foods, are
identified, this issue of which final products should bear
warning labels will arise again and again. Because the pathogenic
safety of a product received by consumers is rarely related
to the package in which the consumer finally receives it,
FDA needs to identify ways in which warnings can be applied
to:
1) Bulk product sold in grocery stores
2) Products served in restaurants on plates
or at salad bars
3) Products served in delis or juice bars.
4) Products sampled at farmers' markets.
If FDA does not have the jurisdiction to handles
these areas, S.T.O.P. is interested in understanding who does
and how that jurisdiction can be consolidated, through the
Food Code, for example, to ensure that consumers received
appropriate warnings at the point of sale.
III. The Need for HACCP Back to the Seed
and Soil
S.T.O.P. strongly supports the extension of
HACCP back to the seed and soil. A significant portion of
initial produce contamination appears to happen in harvest
(as when drop apples are used for unpasteurized juice), in
irrigation (as when produce is sprayed with Cryptosporidium
contaminated water), in fertilization (as when alfalfa seed
fields are fertilized with fluids from manure lagoons), and
in growing (as when runoff from the nearby dairy farm invades
croplands). When using a safety performance criteria, it is
virtually impossible to determine the safety quality of an
output, such as minimally processed juices or alfalfa sprouts,
if you have no control over the pathogen load on the input.
FDA must take steps to ensure that in the next century, all
crop growing farmers take steps to eliminate pathogen loads
on their products by examining their critical control points.
IV. The Need for a Standardized Approach
to Hazardous Foods
FDA's current approach to handling foods that
have caused repeated outbreaks reinvents the wheel each time
a repeatedly hazardous food is identified. Instead of treating
each food as if it were its own, unusual situation, FDA should
develop a standard procedure for how it will handle such foods,
and it should make that procedure known to stakeholders. The
objectives of creating such a procedure would be:
1) To ensure that FDA has a standardized mechanism
to quickly and efficiently inform at-risk consumers of food
hazards as they arise.
2) To encourage industry to look after its
own bad producers by conveying how the entire industry will
be treated if there are repeated outbreaks.
3) To speed up rulemaking on relatively unscientific
regulations such as labels.
This would enable FDA to address many of the
most basic issues that are applicable to all foods once in
a roughly generic manner ("labeling language will generally
look like this," "produce sold in bulk will be handled
this way") and therefore make rulemaking more efficient.
An example process FDA might propose is, when
a food is determined by FDA to be the repeated source of illness
and therefore a public health threat, FDA would respond with
the following:
1. Immediately:
Issue a press release warning at-risk
groups that the food is hazardous.
2. Immediately to one year afterward:
Investigate hundreds of sites to identify
safety issues in the industry
3. Within one month of press release:
Hold a public meeting in Washington, DC
with the NACMCF, industry and consumer groups
4. Within six months (including comment
periods/OMB/etc.):
Expedite a rule requiring warning labels
5. Within one year: Expedite a traceback
labeling rule
6. Within 3 months: Initiate appropriate
research
7. Within 6 months: Propose a HACCP rule
In S.T.O.P.'s opinion, current food safety
conditions at the farm-level are insufficient to prevent repeated
outbreaks. Over time, we are likely to learn that certain
food growing/handling techniques make some foods more risky
than the average. It is important to both consumers and industry
that FDA have methods in place to handle these situations.
V. The Need for Standardized Messages,
Appropriate to the Hazard
FDA's current public relations, marketing
materials, and messages demonstrate a lack of cohesiveness
and of priority setting. As a result, for the same amount
of time and energy, they could be even more effective than
they presently are.
One of the basic tenets of public relations
and communications strategy is to establish what the most
important messages are and repeat them. Establishing which
messages are important helps to ensure that unimportant messages
do not take up valuable mindshare on the part of the target
audience or confuse the target audience with extraneous data.
Repeating the important messages helps to ensure that they
are received.
We would give the following examples of FDA's
messaging over the last three years. In 1997, FDA produced
a short piece entitled "Apple Cider Season Brings Caution,"
as part of its "FDA Reports, Facts from the U.S. Food
& Drug Administration." This document says,
"The Food and Drug Administration (FDA)
advises people in the following high risk groups to drink
only pasteurized cider and juices:
· Children
· Older adults
· People with weakened immune systems,
such as those with HIV, AIDS or cancer."
It also advises, "Children on field trips
to apple cider mills or farm markets should not drink unpasteurized
cider."
This very fundamental message, that the at-risk
groups should drink ONLY pasteurized cider, does not appear
to have been clearly repeated by FDA spokespeople to the press.
In one article, Arthur Whitmore is described as having said:
"'We want to make sure they understand
that little kids really shouldn't be fed fresh juice, fresh
apple juice in particular,' Whitmore said."
No mention is made of other at-risk groups.
Yet in another, Whitmore gives only counsel about the wisdom
of drinking unpasteurized juice, remarking about children's
affection for unpasteurized apple juice:
"'A lot of people are unaware [of the
danger],' said Arthur Whitmore, spokesman for the U.S. Food
and Drug Administration's nutritional department. 'They
think it's a natural product. Kids love it. But if you really
want to reduce your risk, it may not be wise to drink unpasteurized
apple juice.'"
In 1998, the message "these at-risk groups
should NOT drink unpasteurized juices," was simply not
found on FDA's glossy "What Consumers Need to KNOW About
Juice Safety" sheet. Instead, a similar, expanded message
addressing all types of unpasteurized juice was placed on
the second page as the answer to the tenth question
in the "Questions and Answer on the Juice Warning Label
Regulation," dated September 8, 1998, distributed in
the same press kit.
In another example, an article in a spring
1998 newsletter to the White House daycare center,
growing alfalfa sprouts was suggested to parents as a great
activity to do with children. Indeed, the article recommends
"The trick is to buy alfalfa seeds that have not been
chemically treated." At the time that this article ran,
FDA already had data that indicated the alfalfa sprout seed
is the likely source of pathogenic contamination which had
already killed at least one person. Nevertheless, the message
to parents was: sprouts are safe. Yet, in August, 1998, just
four months later, FDA issued a statement indicating that
alfalfa sprouts should not be consumed by children, the elderly
and the immune impaired. Indeed, it would appear that the
only currently available mechanism for improving the safety
of alfalfa sprouts is chemically treating the seed.
In July of 1998, FDA mentioned the following
in its Final Juice Labeling Rule:
"This assignment did not result in
the detection of any pathogens in a finished cider product
intended to be sold to the public. However, FDA's preliminary
findings from this assignment show that one firm's incoming
apples tested positive for Salmonella sp. indicating that
microbial hazards that necessitate effective control measures
are reasonably likely to occur on incoming apples. Moreover,
FDA's preliminary findings show that fecal coliforms and
E. coli were found in the wash water used at several firms,
indicating that the water is of poor quality. In addition
a small number of finished cider products tested positive
for fecal coliforms and generic E. coli was found in 14
percent of the finished product samples."
Yet, rather than alert the public to these
startling facts (that more than 1 in 10 samples were contaminated)
which support FDA's position on unpasteurized juices,
FDA did not publish this information outside of the Juice
Labeling Final Rule. When news reports discussed that FDA
had concluded its investigations, the only message repeated
was that in all of FDA's investigations, E. coli O157:H7
was not found.
One potential mechanism that FDA could use
to help ensure consistency of its communications efforts would
be a sheet of messages for a specific food safety topic intended
for internal use. These messages would be listed in order
of priority based on the need for them to be repeated to and
retained by the target audiences. As more data came in, such
as the results of field studies, the message sheet could be
revised so that data that reinforces the warnings would have
higher priority. Whenever new materials or education campaigns
were developed, they would be driven off of the most recent
message sheets. Likewise, when existing nutritional statements
were made, as in FDA's "Five A Day" campaign, the
agency could ensure that the topmost safety messages were
included.
VI. In Conclusion
Given FDA's need for increased resources to
improve food safety, it is imperative that FDA use its existing
resources as wisely as possible. Typically, when any organization
runs into a series of events, they are initially treated as
individual, unrelated events. From S.T.O.P.'s perspective,
these events are related and until appropriate safeguards
are introduced across all foods, they will continue to occur.
We encourage FDA to take a more standardized approach to its
definitions, its procedures, and its messages in order to
improve the agency's overall efficiency and effectiveness.
Elaine Dodge
Executive Director
Laurie Girand
Advisory Board Member
- Benenson, Abram, Control of Communicable
Diseases Manual, Sixteenth Edition, 1995; pages 271-272.
- Lawson, Kate, "Tainted meat can infect
your refrigerator," Detroit News, February 2, 1999:
"'Last week we handled over 1,400 calls related to
the recall,' says Diane Van, the team leader for the USDA's
meat and poultry hotline, who says its busiest time is at
Thanksgiving, 'but I'd have to say the recall questions
have far surpassed that. We're even getting calls from doctors
asking how to identify the symptoms.'"
- Bill Mar/Sara Lee; Thorn Apple Valley;
Land O' The Lakes.
- Food Labeling: Warning and Notice Statement:
Labeling of Juice Products; Final Rule; Federal Register:
July 8, 2025 (Volume 63, Number 130), Pages 37029-37056.
- Transcript of Proceedings, FDA Technical
Workshop,; Citrus Research and Education Center, University
of Florida, Lake Alfred, Florida, November, 12, 1998; page
34.
- Associated Press-Washington, "Sprout
Recall," September 5, 2025
- Carey, Pete, "Testing Dispute Preceded
Tainted Odwalla Juice", San Jose Mercury News, October
31, 1997.
- E-mail exchange with Dr. Larry Pickering,
Center for Pediatric Research, Norfolk, VA. February 8,
1999.
- Benson, Abram, Ibid.
- Conversation with Dane Bernard, Senior
Director, Food Safety Programs, National Food Processors
Association.
- Fox, Maggie, "U.S. FDA to Require
Labels on Juice Risk ," Reuters, August 26, 1997.
- Salemi, Tom, Hard pressed , "Small
cider mills fear push for mandatory pasteurization,"
Boston Business Journal, October 28, 1997.
- Parent Pages, April 1998, Volume 9, Number
4, 1998 Pages, Inc. P.O. Box 6036, Colorado Springs, CO
80934, 719-632-0916.
- Public Meeting on Sprout Safety, September
28-29, Washington, DC.
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