Remarks prepared for delivery
by Deputy Under Secretary for Food Safety Dr. Merle Pierson,
at the International Association for Food Protection's 91st
Annual Meeting, August 10, 2004, Phoenix, Arizona.
Good afternoon. It's truly a pleasure to speak to you at IAFP's
91st Annual Meeting. IAFP has been serving food safety professionals
nearly as long as the length of time the Meat and Poultry Inspection
Acts and the Food, Drug and Cosmetic Act have been around. This
nearly century-long service has been invaluable to academia,
industry and government. Above all, it has been invaluable for
its contributions to the protection of consumers worldwide,
and we look forward to working together with you as we move
forward in the 21st century.
The organizers of this meeting have again arranged an excellent
program. It is always rewarding to come to this meeting and
discuss food safety issues with colleagues who have been working
in food safety for many years as well as meeting individuals
who are bringing new perspectives.
Advancing food safety is an immense challenge that is only
accomplished through the joint efforts of all stakeholders.
For example, assuring the safety of meat, poultry and egg products,
the area in USDA where I share responsibility, represents nearly
6,500 establishments that must provide safe products for domestic
and international consumers. In addition, we have regulatory
responsibility for all such products imported into the United
States. Although regulation is an important part of the food
safety system, it takes cooperation from government, producers,
processors, educators and scientists, consumers and many others
to effectively protect public health. Your role in providing
the science and new technologies is critical to our success.
There are many examples of how you have provided new insights
into the identification, ecology, growth characteristics, methods
of control, and other factors that have been essential to technologies
and policies for protecting public health.
I would like to present to you today an overview of the USDA/FSIS
role, strategy and outcomes in protecting the safety of products
under our regulatory jurisdiction. Time does not permit discussion
of all aspects of this responsibility, thus discussion of such
areas as inspection force training, consumer outreach activities,
management, and homeland security while critical are not included.
Further discussion of these areas can be found in our "Vision"
papers that I will mention in a few moments.
A Vision for the Future
Last year at your annual meeting in New Orleans, Dr. Murano
shared with you a vision to improve food safety that outlined
science-based initiatives USDA's Food Safety and Inspection
Service (FSIS) would implement to improve public health. This
vision, and the strategies to achieve it, were described in
a document titled Enhancing
Public Health: Strategies for the Future.
Last month, we released a follow-up document titled Fulfilling
the Vision: Initiatives in Protecting Public Health,
as you see on this slide. If you have not had a chance to read
it - stop by the FSIS booth in the exhibit hall after this session
and pick up a copy. Or you can visit our Web site at www.fsis.usda.gov
to read an electronic version.
As you know, the crux of our challenge centers on combating
biological, chemical and physical hazards that range from the
easily understood to those that present new and complex challenges.
Thus, we must not only rely on existing knowledge and strategies
for food safety, but also introduce new approaches.
As part of FSIS' continuing process to meet these food safety
challenges, we prepared, Fulfilling the Vision, a plan
to use the latest in science, as well as to most effectively
use our resources and authorities to further improve our food
These vision documents show how committed the Bush Administration
is to food safety and achieving results from science-based initiatives.
For me, as a food scientist, it has been exciting to work in
Washington with this strong backing to ensure that our food
safety policies are absolutely effective not only for the American
consumer, but for consumers worldwide. For the rest of my discussion,
I will share with you the results we have achieved through the
use of science, risk assessments, and close collaboration with
our partners. These factors were all vital in the initiatives
laid out in our first vision document. Then, I'll cover a series
of new measures described in Fulfilling the Vision,
which we are currently focusing on to further improve the U.S.
meat, poultry, and egg products supply.
Evaluating the Effectiveness of the 2003 Vision
While there may be many approaches to measuring success, we
looked at a number of indicators related to public health outcomes
and pathogen reduction. Such an evaluation is essential to determining
the success of our strategies and developing new ways to combat
threats to public health. As you know, in our high-speed, fast-food
world, it is difficult for some to understand that successful
science is not immediate gratification and it is not easily
measured. But over time, positive results show that our approach
An effective gauge of how our policies and industry practices
are working is looking at how public health is impacted. In
April of this year, the Centers for Disease Control and Prevention
(CDC) reported significant declines from 1996 to 2003 in illnesses
caused by E. coli O157:H7, Salmonella, Campylobacter
Specifically to the products USDA regulates, illnesses caused
by Salmonella Typhimurium, typically associated with
meat and poultry, decreased by 38%. Between 2002 and 2003, illnesses
caused by E. coli O157:H7, often associated with ground
beef, dropped by 36%.
The CDC attributes the changes in the incidence of these infections
in part to the control measures implemented by government and
industry and enhanced food-safety education efforts. I also
want to add that it is important to point out that these results
were only achieved through your advances in science and technology.
We are hopeful that these reductions in foodborne illness will
E. coli O157:H7 E. coli O157:H7 provides
an important example of the results that have been achieved.
I already mentioned the CDC outbreak data. In addition, we are
seeing a significant drop in the percentage of E. coli
O157:H7 positive regulatory samples in ground beef. In 2003
there was a 60% reduction in the number of positive results
compared to 2002.
There have been many changes and new approaches taken over
the past couple of years taken by industry and FSIS to more
effectively reduce the prevalence of E. coli O157:H7
in ground beef. Beginning in October 2002, FSIS required all
beef establishments to reassess their HACCP plans relative to
the potential presence and control of E. coli O157:H7
in raw beef. Then FSIS personnel conducted the first-ever comprehensive
audits of HACCP plans in nearly 1,800 beef establishments. Sixty
two percent of those plants made major improvements based on
their reassessments, and 60% added O157:H7 as a pathogen likely
to occur. I believe this sequence of events initiated by FSIS,
will continue to contribute to the kind of dramatic results
we have been seeing.
We can look at the findings from our microbiological testing
program for E. coli O157:H7 in another way.
- In 2001, our testing program yielded 59 positive results
out of 7010 samples;
- In 2002, there were 55 positive results from 7025 samples;
- In 2003, there were 20 positives out of 6584 samples; and
- So far this year, there have been only eight out of 4279
This certainly is a credible testament to the value of cooperation
and application of science, technology and better process control
in preventing contamination of ground beef by this very difficult
and challenging pathogen.
Our most recent initiative in further reducing E. coli
O157:H7 has been a series of directives issued in May 2004 that
provided risk-based guidance to inspection personnel. For example,
establishments that have designed and implemented sampling and
verification testing and have a high degree of confidence of
finding the pathogen in both trim and finished ground product
will be sampled less frequently by FSIS than other establishments
not having such programs. In addition, we will weigh our sample
scheduling process so that an establishment producing a large
volume of raw ground beef products will be sampled more frequently
than an establishment with a lower volume of production of raw
ground beef products. This type of targeting will deploy our
resources more efficiently and effectively. These directives
also provide for a number of other actions that are the subject
of a series of public meetings that FSIS has been conducting.
If you need to know more about these actions I refer you to
the FSIS Web site.
Next, I will mention initiatives related to Listeria monocytogenes
(Lm). Consumption of foods contaminated with this pathogen
can result in serious public health consequences to certain
susceptible groups of people, and preventing its contamination
of ready-to-eat (RTE) meat and poultry products is a high priority
for USDA. Currently we have a zero tolerance policy for Lm
in RTE products.
CDC data on foodborne illnesses has indicated that the incidence
of infection from Lm decreased between 1996 and 2001.
However, the level then reached a plateau, so it became evident
that additional targeted measures were needed. In addition,
we also knew that since the 1990s, there had been a major Listeriosis
outbreak in the United States every two to four years.
Clearly breaking the all-too-familiar cycle is critical to
lowering the approximate 500 deaths caused by Lm each year.
As part of our overall risk assessment process, we looked at
a risk ranking of products and estimated the potential level
of exposure of three age-based U.S. population groups to Lm
in 20 food categories. We then took these data and related them
to public health consequences.
Through studies conducted by NFPA as well as ARS and others
we were able to obtain essential data on Lm in various
RTE products, and thus, better target policies for intervention
These surveys then served as key information for the development
of an FSIS risk assessment on Listeria in RTE meat
and poultry products. The risk assessment, in conjunction with
a previously released FDA/FSIS risk ranking, public comment
gathered on the topic and a peer review of the risk assessment
provided important data for designing a final Lm rule.
On June 6, 2003, FSIS issued an interim final rule on control
of Lm in RTE meat and poultry products. The rule outlined
three strategies that an establishment could choose from to
control the pathogen depending on its product(s) and the environment
in which it operates. The frequency of FSIS conducted verification
activities would then be risk based with most conducted when
an establishment relied solely on sanitation practices for Lm
control while there would be fewer where an establishment had
more aggressive process control measures and interventions.
Late last year, we released data that showed a 25 percent
drop in the percentage of positive Lm regulatory samples
from the year before, and a 70 percent decline compared with
years prior to the implementation of HACCP. We trust that with
the measures implemented by industry and FSIS policies this
trend will continue.
To determine the impact of the Listeria rule in terms
of changes made by establishments, we surveyed our inspection
personnel who were located in 1,400 establishments producing
RTE meat and poultry products. We found that more than 87% of
the plants changed their operations in one way or another to
more effectively control Lm. Such changes included
implementing Listeria testing, the use of antimicrobial
agents, and post-lethality treatments. We will continue to monitor
our progress on reducing Lm and make any necessary
We have seen similar reductions in Salmonella. As you
are no doubt aware, a couple years ago we issued new procedures
for using Salmonella performance standards as a verification
tool for food safety. Under these new procedures, instead of
waiting for two consecutive failures of tests to trigger an
in-depth review of plant's SOP and HACCP plans, reviews are
initiated after any series of tests fails to meet a standard.
This process and other science-based initiatives, including
those implemented to reduce O157:H7 played a significant role
in reducing the prevalence of Salmonella in raw meat
and poultry regulatory samples. Salmonella in raw meat
and poultry regulatory samples has dropped substantially over
the past six years. Out of the number of regulatory samples
collected and analyzed by FSIS in 2003, 3.8 percent tested positive
for Salmonella, as compared with 4.29 percent in 2002;
and 10.65 percent in 1998.
Although our regulatory data may not represent the prevalence
of these pathogens nationwide, it is certainly indicative of
a downward trend. Our pathogen reduction policies are also having
a direct impact on the decreasing number of recalls over the
past two years. The number of Class I, or high risk, recalls
has nearly been cut in half from the total observed in 2002.
In the first half of 2004, the number of Class I recalls is
16, down from 29 in the first half of 2003.
Bovine Spongiform Encephalopathy (BSE)
Recalls are just one method to protect public health;
however, they are, by far, not our only means. A significant
amount of public health protection comes from the behind-the-scenes
efforts to improve our systems and infrastructure that go unnoticed
every day. The December 23, 2003, recall of beef products following
the announcement of the detection of a BSE positive cow from
a slaughter operation in Washington state could be seen by many
as a precursor to the implementation of our BSE measures.
However, we had completed an extensive amount of groundwork
on FSIS' four BSE measures before Secretary Veneman's major
policy announcements on December 30. Our swift actions to get
the one notice and three interim final rules, as you see on
this slide, published in 13 days were unprecedented. The process
normally would have taken several months; however, with strategic
planning this normally daunting task was achieved very quickly.
The implementation of our BSE rules is a testament to the importance
of planning and having structures ready to protect public health
in case of a finding such as BSE occurs. Furthermore, these
regulations add a significant level of protection to an already,
existing strong food safety system.
You can read more progress and strategies for reducing pathogens,
as well as our BSE measures in Fulfilling the Vision.
While it is wonderful to stand up here and talk about what has
been done, the most important part of this document is, in fact,
our continuing vision for the future. Again, I stress that to
move forward effectively and better protect public health we
have to do so as a cooperative effort that is based on science.
I want to briefly outline four of these initiatives with you
Enhanced Data Integration
Our first initiative is really more of a challenge that we have
given ourselves. This is to anticipate and predict food safety
risks through enhanced data integration in order to protect
public health. One significant way to accomplish this is through
the analysis of FSIS regulatory sampling data as well as other
sources of data in order to detect trends and identify connections
between persistence, prevalence and other factors such as practices
employed by plants, seasonal variations, and establishment size.
However, there is a missing link here. FSIS would need access
to industry data. Including data collected by the establishment
would add robustness to FSIS' information and improve the quality
and validity of decisions that are made. Ensuring the availability
of data to FSIS from industry, academia, States, consumers and
others will be necessary to move forward. One way to accomplish
this may be through the establishment of a third-party repository
to provide data integrity and confidentiality. Obviously, we
are very early in this initiative, and I encourage you to stay
tuned to this issue as more details become available in the
Apply Risk into Regulatory and Enforcement Activities
The next initiative is for improved application of risk into
regulatory and enforcement activities. We are beginning to field-test
the Hazard Control Coefficient, or HCC, which is a measurement
of the effectiveness of pathogen controls used by individual
The HCC establishes the level of plant compliance through an
analysis of in-plant and Agency verification testing, as well
as inspection data. The HCC will help us better understand the
frequency and types of food safety failures so that more appropriate
responses, based on risk rather then a one size fits all mentality
can be designed and implemented.
Associate Program Outcomes to Public Health Surveillance
Our third initiative is to improve the association of program
outcomes to public health surveillance data. We are working
closely with the CDC and the Food and Drug Administration on
developing and analyzing public health trends. Data that link
foodborne illness outbreaks with specific foods need to be connected
with prevalence data of specific pathogens in specific foods.
The Foodborne Diseases Active Surveillance Network, or FoodNet,
allows our partners and us to integrate this data by determining
the burden of foodborne disease, monitoring foodborne disease
trends and determining the extent of foodborne diseases attributable
to specific foods.
Improving Food Safety Beyond our Borders
The final initiative I will mention is our continued dedication
to improving food safety beyond our borders. Our goal is to
work with our partners in the western hemisphere to develop
common food safety standards and harmonize food safety education,
information and communication throughout the region.
To achieve this, last week, we announced the establishment
of a Food Safety Institute of the Americas. This institute will
be a cooperative educational and research organization designed
to promote food safety and identify and develop educational
programs throughout the Americas.
The implementation and maintenance of the strategies found
in the vision paper have led to significant measurable advances
in FSIS' mission to protect public health. These initiatives
will provide an essential and important foundation for the future.
Not only is it critical for us to continue to refine and enhance
these advances based on our current regulatory authority and
available scientific knowledge, it is essential that we continue
to modernize our inspection system through risk-based approaches
and further refine our management agenda in order to have the
flexibility to meet ever changing threats to public health.
Furthermore, we will continue to engage the scientific community,
public health experts and all interested parties in an effort
to identify science-based solutions with public health outcomes.
I look forward to continue working with IAFP and its membership
to fulfill the initiatives laid out in our vision paper. As
I mentioned, you can pick up one here at our booth, or read
a copy that is posted on FSIS' Web site at www.fsis.usda.gov.
We welcome the input of all interested parties and encourage
the free exchange of ideas to further enhance the safety of
the U.S. meat, poultry and egg products supply. Thank you.