Prepared remarks for USDA Under Secretary for Food Safety Dr. Richard Raymond,
to be delivered at the Annual Combined PulseNet Update and National Foodborne Epidemiologists
Meeting, on April 3, 2006, in Miami, Florida.
Note: Slides are available in an attached PDF document; individual
pages are linked within the text.
Thank you. I appreciate this chance to speak with you about
USDA's efforts to combat Salmonella and lay the foundation
for a more robust risk-based inspection system.
It's also a real pleasure to be here to help celebrate the
10th anniversary of PulseNet. Anniversaries like this offer
us an important opportunity to learn from past challenges, celebrate
current achievements and plan for future success.
Some of you might already know this, but USDA is also celebrating
an important milestone. This year marks the 100th anniversary
of the passage of the Federal Meat Inspection Act. The Act ushered
in a new era of food safety on a national level.
However, it was based on visual examination for visible signs
of disease. The future demands that we be able to focus on the
things which the human eyes cannot see, the nose cannot smell
and that our fingers cannot touch.
Your future work, insight and effort will be critical to ensuring
that our food safety system will be able to meet these demands
in the next century. I also know that your work is helping to
save lives every day. You can never know just how many lives
you save every day, but that's what's unique about the public
health field. You might have saved a thousand, but just one
is an accomplishment.
There are two things that we can be sure about PulseNet. The
first is that FSIS' food safety activities are built upon the
strong foundation provided by your microbiological and epidemiological
The second is that I don't want to imagine what my job would
be like without the support that PulseNet provides to USDA.
PulseNet is critical in helping us determine if an outbreak
is occurring especially when cases are geographically dispersed
across the country.
But before I go any further, I'd also like to recognize the
important contributions that local and state epidemiologists
and their health departments make every day to food safety and
[Click to the next slide as Dr. Raymond mentions each leg of
4) Federal Government
5) State Government
6) Local Government
7) Broken stool
Coming from state government, I realize and truly value the
important role states and local governments play, and I'll do
whatever it takes to improve local, state and federal cooperation
for the well-being of the American public.
That importance was once again highlighted in a recent recall
of adulterated product. I'm sure those from the Minnesota Department
of Health already know what I'm talking about.
Thanks to an intense collaborative public health investigation
between the Minnesota Department of Health, the Minnesota Department
of Agriculture and FSIS, we were able to link exposure to a
specific raw poultry product to human illness.
That investigation helped FSIS make the determination that
the raw chicken entrees' frozen state, labeling and cooked appearance
could cause consumers to believe these raw products were pre-cooked.
If that happened, then consumers might not follow the cooking
instructions and that would mean they would be at additional
risk for illness. And that's exactly what did happen.
We used all the tools at our disposal including epidemiological,
microbiological and traceback evidence, as well as patient histories,
to make the link between exposure to that particular product
and the illnesses that the Minnesota Health Department was seeing.
In fact, this investigation led FSIS to recall 75,800 pounds
of frozen stuffed chicken entrees because they were adulterated
and could have been unhealthful or unfit for human consumption.
This kind of cooperation between the state and federal government
is absolutely critical to ensuring the safety of our food supply.
This quick response, which I believe helped to prevent further
illnesses, was made possible by the efforts of the Minnesota
Health Department. But I want you to know that I'm well aware
that the dedication and professionalism they demonstrated isn't
unique to Minnesota.
I mentioned earlier that anniversaries give us a great opportunity
to celebrate our current achievements. I am proud to say that
we have a number of food safety successes to talk about. Thanks
to your dedication, we've seen dramatic declines in the prevalence
of pathogens in the products that we regulate and the numbers
of foodborne illnesses stemming from these pathogens.
Another significant measure of how our science-based policies
and control measures in plants are affecting public health can
be found in an annual report published by the CDC.
According to the CDC, there have been significant declines
from 1996 to 2004 in illnesses caused by E. coli O157:H7,
Listeria monocytogenes, Campylobacter, and
Compared to the 1996-98 baseline, illnesses caused by E.
coli O157:H7 decreased by 42 percent. I'm happy to report
that we met the Department of Health and Human Services' Healthy
People 2010 objective for E. coli O157:H7 six years
Taken together, these human health results and decreasing numbers
of pathogens in our sampling program indicate that our risk-based
approach is working. All of this is good news, but we still
have areas of concern.
According to our sampling data, the number of product samples
positive for Salmonella has been on the rise in several
poultry categories over the past few years, specifically in
young chicken (or broiler) carcasses.
The four-year trend of rising rates in broiler carcasses does
not bode well for public health. The rates have risen nearly
50 percent in just three years, and you do not have to be a
foodborne epidemiologist to know that this isn't a positive
The CDC's most recent FoodNet report is not much better. It's
clear that the overall incidence of Salmonella infections
remains far above our objective. In 2003, there were 14.5 cases
of Salmonella infections per 100,000 people. That's
43,500 people per year with culture proven Salmonellosis.
The CDC estimates that the actual number could be over one
million. That's a tremendous burden on human health.
While CDC did report that Salmonella infections dropped
eight percent, only one of the five most common strains, which
accounted for 56 percent of the reported Salmonella
infections in 2004, declined significantly. That strain was
Salmonella Typhimurium, which declined 38 percent.
Salmonella Enteritidis and Salmonella Heidelberg
neither increased nor decreased significantly. Incidences of
Salmonella Newport increased by an alarming 41 percent.
Given the challenge we face with Salmonella, it's
imperative that we take a risk-based approach to investigating
and controlling the incidence of Salmonella in meat,
poultry and egg products. This is an approach that will be strengthened
by your microbiological and epidemiological investigations.
I believe that we can leverage new technologies and cutting
edge research, not only to reach the Healthy People 2010 objective,
but to drive the numbers even lower.
Since the prevalence rate in broiler chickens seems to be a
trouble spot, we are revising the performance measure for Salmonella
on this particular product. This is in part due to three weaknesses
we have identified in the current measure.
The first is that the measure is scientifically unsound. The
FSIS regulatory testing program that is the source of the data
used in the current performance measure does not provide a true
measure of the pathogen's prevalence.
For example, if samples from an establishment are only taken
early in the first shift, then those samples are not providing
us with an accurate understanding of the environment or the
workforce characteristics of that establishment's second shift.
The second weakness is that the current measure is for generic
Salmonella, and includes serotypes that are not, or
are rarely, attributed to foodborne illness. There are many
known serotypes of Salmonella found in broilers. Each
serotype that can causes human illness, does so with varying
severity. In fact, the most common serotype has been found not
to be a significant factor in human foodborne illness.
The third weakness is that the current testing program is not
consistent with FSIS' goal of transitioning to a more robust
risk-based inspection system.
To generate the data needed to report on the current measure,
FSIS would need to continue scheduling a sample set for every
plant each year under the current strategy. But plant process
controls for Salmonella vary widely, as do their results.
Since 2003, aggregate percent positives in sample sets have
increased each year from 11.5 percent in 2002, to 16.3 percent
in 2005, while still remaining within regulatory performance
standards. In order to improve program performance, FSIS is
working to strengthen its verification testing program by making
it more risk-based.
The image on the screen illustrates an analysis of 103 large
broiler plants where FSIS completed five or more HACCP verification
sets from 1998-2004.
Twenty-six of the 103 establishments (25%) routinely demonstrated
Salmonella control, with six or fewer Salmonella
positive tests out of 51 tests per set. Another 46 establishments
(45%) exceeded half the standard without failing at least once
and another 31 establishments (30%) exceeded the standard at
You can see that a substantial number of the plants were below
50 percent of the existing performance standard on every set.
If those plants can accomplish it then we believe others can
do the same.
The plants that fail one or more sets, and the plants that fluctuate
above and below 50 percent but never fail, will frequently have
a set where they perform very well.
This helps to explain why we find that the majority of set
results are below 50 percent of the existing Salmonella
prevalence standard. Even with 35 percent of the analyzed establishments
failing one or more sets, less than 25 percent of those sets
were above the standard.
We know that lowering the prevalence of Salmonella
in poultry products is possible. We have seen one plant with
a Salmonella prevalence rate of 30 percent reduce that
rate to two percent after an FSIS food safety assessment. Our
goal as we move forward must be to make these reductions a reality
across the board.
FSIS has also found strong evidence that plants that have consistently
achieved a percent positive rate in sample sets at or below
half the current regulatory performance standard are less likely
to produce raw product that have the serotypes of Salmonella
that cause human illness.
As a result, achievement of performance goals established under
the new measure would provide a better indication of process
control and relate more directly to the improved safety of broilers.
We recently announced an initiative to reduce Salmonella
in meat and poultry products. It incorporated 11 steps, including
increased sampling in plants where it's most needed and quarterly
publication of nationwide Salmonella data by product
The initiative uses the old carrot and stick approach to encourage
change by offering establishments the possibility of improved
efficiency, incentives and also disincentives based on their
I'm not going to get into the specifics of our 11 step plan
today. That information, as well as numerous presentations on
how to further reduce the prevalence of Salmonella
F — pre-and post-harvest; — can be found on FSIS' Web site at
However, I'm confident that this initiative will help FSIS
to be proactive and take action before people get sick.
Robust Risk-Based Inspection System
FSIS must develop these critical abilities further and that's
why it is so important that we begin to lay the foundation for
a more robust risk-based inspection system.
I want to focus our time and valuable resources on prevention,
rather than on response. Command and control was the old agency
mantra. We are now after a common sense, cost-effective public
health strategy that best serves the American consumer by preventing
I know with your continued support, we can further improve
upon the food safety successes that we have already seen.
Our current system, while strong, is not suited to the future
realities of food safety and public health, and we will need
the ability to anticipate and quickly respond to food safety
challenges before they negatively affect public health. An enhanced
risk-based inspection system offers this ability.
This is vital, as is a system that will allow us to use our
finite resources more effectively and efficiently to further
improve food safety.
However, it is important to note that FSIS already uses a risk-based
approach to food safety. Our goal is to further enhance and
strengthen that system so that we are prepared for the food
safety challenges in the next century.
I assure you that we will use a transparent and inclusive process
to seek input from all of our food safety stakeholders on a
wide range of issues related to creating a more robust risk-based
At the last meeting of the National Advisory Committee on Meat
and Poultry Inspection (NACMPI) in November, the Committee recommended
a third-party approach to assist us in reaching out to, and
gaining input from, our stakeholders.
We are now in the process of selecting a neutral third party
and a subcommittee of NACMPI has been established to provide
regular, ongoing guidance. I urge everyone here to take an active
role. Your experience and knowledge is invaluable.
We all know that we can save lives through sensible science-based
policies, and together I know we will do just that.
As we move forward in our fight against Salmonella,
and toward a more robust risk-based inspection system I want
you to know that we are also dedicated to improving our food
A focal point to our strategy is the enhancement of the Food
Emergency Response Network (FERN), which is a joint laboratory
partnership between FSIS, the Department of Health and Human
Service's Food and Drug Administration (FDA), and selected state
public health laboratories.
We saw what happened to lab capacity and U.S. Postal Service
efficiency when just a few letters were sent containing Anthrax
to just a few persons. The same can happen again with one phone
call to the Post indicating that the meat supply is contaminated
This is why we are working hard to provide 23 selected existing
state or local laboratories with the necessary training, equipment
and supplies they need so that surge capacity can be handled
more quickly and closer to home.
From a public health standpoint, an investment in FERN is absolutely
essential if we want to prevent, or mitigate, the loss of life
and economic hardship that could result from a hoax, or an intentional
or unintentional incident that affected the food supply. We
must also be prepared for the distinct possibility that one
or all of our three FSIS laboratories could be incapacitated
in an attack on our food supply.
Before I close, I want to remind you that we already have a
strong system in place. But we must continue to improve and
enhance our food safety system. A system not moving forward
is a system falling behind.
Since taking this job I have encountered a lot of people who
have told me that further dramatic improvements in food safety
is just not possible. I don't believe that for a moment and
let me tell you why.
I believe it is possible because I know the history of public
health. After all, public health's entire history is really
just a long list of achievements that were at one time thought
impossible. It is the work of dedicated scientists like you
that ensures that the impossible will eventually become commonplace
given enough time.
Did you know that 100 years ago, one in five coffins contained
a child under five years old? Today that number is only one
in 100 coffins. That is an amazing accomplishment that has had
a profound impact on our society and everyone in this room.
Clean water, sewage, vaccines and antibiotics have been critical
— but a safe food supply has also played a role in this amazing
I know that together we can continue to lower the number of
After all, the bottom line is that we all have the same objectives
— safe food and healthy people. We must never lose sight of
these common goals.
Thank you again for everything that you do to ensure the safety
of the U.S. food supply.