Remarks prepared for delivery by Under
Secretary for Food Safety Dr. Elsa A. Murano, at the National Food
Processor's Association's Annual Conference, Washington, DC, May
Good afternoon. It is wonderful to be here at NFPA's annual convention.
I know many of you are here from out of town, so I want to welcome
you to Washington, D.C. Even though "D.C." currently stands for
District of Cicadas, not the District of Columbia, I hope you will
have the chance to get out and see some of this city's wonderful
In Washington, people talk about their inspiring view of the Capitol
or the monuments, and the sights often inspire them to work harder
and better. Actually, I can't see any of the monument or the Capitol
from my windows. However, my view is inspiring nonetheless. The
view in my office is quite awesome; humbling and challenging all
at once. I am referring to a famous portrait of Louis Pasteur hanging
on one of the walls, examining an animal spinal cord. One of the
things I most admire about Pasteur is that he disagreed with the
popular attitude of the day, "science for science's sake;" he felt
this philosophy did not properly serve the people of the 19th century.
He believed that science should have practical applications that
could be used to improve the lives of others and not be some purely
The opportunity to make a difference in people's lives has always
inspired me. This year, I had the pleasure of addressing the graduating
class at Texas A&M Kingsville, and I must tell you that being back
on a university campus brought back great memories. Back in my teaching
days, I would spend this time of the year reviewing my research
and teaching agenda, reflecting on what had been done in the past
year, and outlining the areas that still needed to be addressed,
either in my classroom or in the laboratory. Our lives are so busy
that it is difficult to take a step back and look at the "big picture."
Yet this self examination is vital to ensure that we evolve, not
I am currently conducting this same review process in my role as
Under Secretary for Food Safety. We have made significant progress
over the last 3 years, and I have some great news to share.
First, I want to touch briefly on the Bovine Spongiform Encephalopathy
(BSE) issue. Since the discovery of the "cow that stole Christmas,"
BSE has been front and center with us, as it has with everyone who
has concerns about public health, food safety, or their livelihoods
in this industry. The measures that the Agency has taken to further
prevent BSE demonstrate how committed the Bush Administration and
the Department of Agriculture are to protecting public health and
improving our food safety system through sound, science-based measures.
The four BSE regulations listed on this slide are indeed aggressive.
We are quite confident that these measures will further enhance
our efforts to prevent BSE from entering the U.S. food supply. We
are currently in the process of reviewing all the comments received
on the interim final rules. We received about 22,000 comments, so
it will take us a bit of time to go over them all. However, go over
them we are and I assure you that when the final rules are issued,
they will be based on science.
The American public remains confident in the U.S. meat supply -
and with good reason. Organizations such as NFPA have taken a key
role in tackling the BSE challenge, building on their reputation
as leaders in the area of food safety. I want to take a minute to
thank all of you for your cooperation and collaboration in those
first few days as we recalled the beef connected to the positive
BSE finding. The coordination between all parties, including NFPA
members, was a key factor in getting the word out.
Working together has been critical in addressing the BSE challenge.
This is absolutely what we need to improve public health - greater
cooperation, communication, and coordination over the safety and
wholesomeness of meat products. Through USDA's actions and industry's
commitment to produce safe products, consumer confidence in the
safety of our food supply has not wavered.
Significant Food Safety Advancements
The level of confidence remains strong, in part because of the
significant advancements that we have made in the past year. One
of these has been improvements in implementation and verification
of SSOPs and HACCP, leading to a dramatic decline in the number
of meat and poultry product recalls during 2003. As we see here
on the following slides, the number of Class I recalls has nearly
been cut in half from the total of the previous year (2002). This
is an indicator that our scientifically-based policies and programs
are working - and you (industry) are making a difference
to ensure that the American public receives the safest food possible.
Other indicators of our success last year include reductions in
the trend of pathogens that we found in meat and poultry regulatory
samples. Late last year, we released data that showed a one-year,
25 percent drop in the percentage of positive Listeria monocytogenes
regulatory samples from the year before, and a 70 percent decline
compared with years prior to the implementation of HACCP. Most significantly,
we are cautiously optimistic that this downward trend will continue,
due to the regulation issued in 2003 (last June) for establishments
producing ready-to-eat products where Listeria monocytogenes
is a concern. Let me tell you why.
The backbone of the Listeria rule was a very thorough
quantitative risk assessment, which provided a road map to determine
the practices that industry should follow in order to exert the
greatest control over this pathogen in ready-to-eat meat and poultry
products. The risk assessment showed that testing the processing
environment was important, in that it would help find the organism
in the niches where it may reside, allowing processors to target
and eliminate it from the plant environment before it would contaminate
product. Most significantly, the risk assessment showed that the
measures that would yield the greatest public health protection
were those that would inhibit and/or eliminate the organism from
It has not quite been a year since this regulation was published,
yet its impact has already been significant in terms of the change
it has effected on what establishments do to prevent product from
harboring this organism. Pay attention now, because what I'm about
to tell you is news. We recently conducted a survey of 1,400 establishments
producing ready-to-eat meat and poultry products, and found that
more than 87% have changed their operations in one way or another
to more effectively control Listeria monocytogenes. For
example, more than 57% started testing for Listeria in the plant
environment (not just product), more than 27% have initiated the
use of an antimicrobial agent to inhibit the growth of this organism,
and 17% started using post-lethality treatments. Of course, there
were many companies that did not have to change anything, because
they were already implementing science-based measures like these
in their process. So the bottom line is that this rule challenged
those in industry that had not begun to implement these scientifically
based measures, to do more to prevent contamination with this pathogen.
Our measures to further prevent E. coli O157:H7 contamination
of ground beef have also yielded similar decreases in the levels
of this pathogen. To date, FSIS' scientifically trained personnel
have conducted the first-ever comprehensive audits of fifteen hundred
and fifty beef establishments' HACCP plans. Sixty two percent of
those plants made major improvements based on these reassessments,
and sixty percent added E. coli O157:H 7 as a pathogen
likely to occur. As a result, we are seeing a significant drop in
the percent of E. coli O157:H7 positive regulatory samples
in ground beef. In 2003, of the E. coli O157:H7 samples
collected and analyzed, 0.31 percent tested positive, compared to
0.78 percent in 2002 - or a 60% reduction. This is a definite improvement
- and although these figures represent regulatory samples, and are
not necessarily representative of the prevalence of this pathogen
nationwide, they are representative of a trend downward, and a signal
that our science-based policies are working.
And for Salmonella, we issued new procedures for detecting
this pathogen. Instead of waiting for three cycles of tests, the
discovery of a second Salmonella positive now triggers
a review of an establishment's HACCP plan. Due to this process and
other science-based initiatives, the rate of Salmonella
in raw meat and poultry regulatory samples has dropped by 66% over
the past six years and by 16% compared with 2002. As we look closer
on this graph, we see that out of the number of regulatory samples
collected and analyzed by FSIS between January 1 and October 31,
2003, 3.6 percent tested positive for Salmonella, as compared
with 4.29 percent in 2002; and 10.65 percent in 1998. Again, these
figures represent a downward trend in our regulatory samples.
I'd like to say that although our regulatory data may not represent
the prevalence of these pathogens nationwide, it certainly is indicative
of a statistically significant downward trend. However, the real
proof of whether our policies are working to protect the public
is in determining whether they are impacting public health directly.
Well, as a public health official, I am just thrilled that just
last month, the CDC, in its annual report on the incidence of infections
from foodborne pathogens, noted significant declines from 1996 to
2003 in illnesses caused by E. coli O157:H7 (42%), Salmonella
(17%), Campylobacter (28%) and Yersinia (49%).
Specifically to the products we regulate, illnesses caused by Salmonella
Typhimurium (typically associated with meat and poultry) decreased
by 38%. Most significantly, between 2002 and 2003, illnesses caused
by E. coli O157:H7, typically associated with ground beef,
dropped by 36%. That's a one-year reduction! This reduction in E.
coli O157:H7 illnesses brings the U.S. very close to achieving
the 'Healthy People 2010' goal of 1.0 case per 100,000 people. We
are very hopeful that if we all continue to do our part, this reduction
will not be just for one year, but will continue from now on until
we have achieved the greatest reduction possible in the illnesses
caused by this pathogen.
CDC attributes the changes in the incidence of these infections
occurred in the context of control measures implemented by government
agencies and the food industry, enhanced food-safety education efforts,
and increased attention by consumer groups and the media. As you
all certainly know, in 1997 FSIS implemented the Pathogen Reduction/Hazard
Analysis and Critical Control Point (HACCP) systems regulations
in meat and poultry slaughter and processing plants.
This is very exciting news and promises to make this summer grilling
season one of the safest ever. Further, this data validates our
scientific approach to improving public health through safer food.
These results also demonstrate your commitment to food safety and
I commend you for all of your efforts.
Challenges for 2004
However, there is always room for improvement - and this is where
we need to identify our outstanding challenges and determine ways
to overcome them. Louis Pasteur said "in the realm of science, luck is only granted to those who are prepared." Food safety is too important
to be left to guess work or luck; we must be prepared to identify
and meet challenges head on.
Challenge Yourself, Challenge Others
This is not a challenge you need to take on singularly. You need
to challenge others to take a responsibility for improving food
safety and public health. Hold your suppliers accountable for providing
the cleanest raw product possible. If you are vertically integrated
then examine ways in which you can apply HACCP-oriented principles
in husbandry. Reexamine your processing lines and make sure that
your critical control points are scientifically verifiable and are
being verified day in and day out.
It is critical that every segment of the farm-to-table chain be
held accountable for providing the safest product possible to the
next segment of the chain. The principles of HACCP are the standard
accepted throughout the world
a standard that we know works. HACCP
is the most scientifically advanced process for food safety worldwide
and it gives us the assurance that potential hazards are controlled
and eliminated from the food production cycle.
Holding Ourselves Accountable
USDA's FSIS, too, is holding itself accountable for improving
public health. When I first joined USDA almost three years ago,
I established five goals, a road map of improvements for our food
safety mission. If you attended NFPA's annual meeting last year,
you heard about them:
- To improve the management and effectiveness of our regulatory
- To ensure that policy decisions are based on science,
- To improve coordination of food safety activities with other
public health agencies.
- To enhance public education and
- To protect FSIS regulated products from intentional contamination.
We outlined specific initiatives to make sure we fulfilled those
goals, and thereby improved health outcomes for American families.
These initiatives were reported in our food safety vision document,
Ensuring Public Health: a Vision for the Future. (If you
haven't received a copy yet, we have copies here in the back of
the room.) As part of our continuing process to evolve, we are currently
evaluating where we stand on these items and are preparing to publish
a sequel, Fulfilling the Vision. This detailed plan should
be available in July and it will drive our policies and actions
during the coming year.
This vision is not just words on paper. We are committed to seeing
this vision through and our budget request for 2005 reflects this.
In addition to budget increases in key program areas that I will
mention later, we have requested an additional 9.5 million to further
support our efforts to protect the food supply from intentional
contamination. Food security has been part of FSIS's mission every
day for almost a hundred years and FSIS leads the efforts for USDA
on bio-security. These funds will increase our prevention efforts
in bio-security with the addition of 37 new positions and funding
to test for additional threat agents. 2.5 million has been earmarked
for upgrading laboratory facilities and an additional two million
to train our inspectors specifically on bio-security issues.
Training has been at the top of our priority list since
I joined the Department and it is the first initiative we outlined
in the current vision paper. In April 2003, FSIS inaugurated
new Food Safety Regulatory Essentials (FSRE) training, which is
designed to better equip inspection personnel in verifying an establishment's
HACCP food safety system. All trainees received training in the
fundamentals of inspection, covering the Rules of Practice, Sanitation
Performance Standards, and Sanitation Standard Operating Procedures
(SSOP). Customized food safety training is then provided based on
the types of products being produced at the establishments where
inspectors are assigned. As of the end of last year, more than 1,000
individuals have completed this customized job training regime.
During 2004 FSIS is also training all new entry level slaughter
establishment inspectors and veterinary medical officers in technical,
regulatory and public health methods. We are also looking at expanding
the types of training in the future to meet evolving Agency needs
For the 2005 fiscal year we have requested over a 50 percent increase
in the FSIS training budget. Four million of the requested 7.1 million
would be used to increase the number of entry-level inspectors receiving
formal classroom training from 20 percent to 100 percent. Under
this proposal, all new inspectors will receive formal training on
how to identify and respond to food safety problems. New employees
will be required to demonstrate mastery of training in order to
be certified to assume inspection duties. An additional $3.1 million
has been requested to supplement training for current on and off
line field employees to improve enforcement of Hazard Analysis and
Critical Control Point/Pathogen Reduction regulations and food safety
sampling. These frontline employees are responsible for the making
the critical decisions that products are safe; thus it is essential
to have a scientifically and technically trained workforce.
As a side note, let me say that I am tremendously fortunate to
have someone at the helm at FSIS who is a true believer in the benefits
of a well-trained field force. Dr. Barbara Masters brings tremendous
credibility, common sense, and above all, integrity to the position
of acting Administrator. She and I are in locked-step in our commitment
to public health, and believe strongly that science is the way to
get us there.
Our second initiative is furthering the use of innovative
food safety technologies. I believe that we must encourage
the use of safe and effective interventions, and do we all we can
to ensure that we facilitate the process.
One way we can do this is by hosting public scientific symposia.
Last December in Omaha, Nebraska, we met to discuss the development
and use of new food safety technologies to enhance public health.
The dialogue and ideas generated at that meeting were also very
helpful in exploring how plants can utilize new technologies in
I know NFPA's members are very active in the development of new
technologies, so you are no doubt aware of the establishment of
our New Technology Office in August 2003. This group is tasked with
expediting the implementation of safe interventions at slaughter
and processing establishments. When we completed our risk assessment
for Listeria in ready-to-eat products last year, it struck
me how important interventions are in mitigating risk.
Our New Technology staff is an experienced team of 12 veteran FSIS
employees, people who serve as the single portal for all new technology
submissions. We designed this group to better manage the new technology
process and allow for implementation as quickly as possible. They
are also making sure that all FSIS personnel are aware of new technologies
and where they are being used.
To increase the pool of new technology submissions, we have developed
a New Technology web page where parties may submit their information
on-line. We also have established an e-mail address, FSISTechnology@fsis.usda.gov,
for interested groups to learn more about how to have their products
or ideas considered. I am happy to report that we have received
over 37 proposals for new food safety technologies since we have
streamlined the submission process.
We are also working closely with our sister agencies to implement
effective, validated technologies. The addition of lactoferrin to
our tool box of food protection methods last year is a good example
of how this is working. We must not let bureaucratic red tape stymie
the introduction of new technologies. Food safety advances can't
languish at the bottom of an overfilled "in" box.
Your leadership can help us in this effort. As new technologies
are developed, they must be validated. Publication alone is not
enough to show safety and success. While FSIS will encourage and
support new technologies, you must follow through on your end as
well. Correct validation is expected and indeed required, as our
Agency will re-verify the results.
Our third initiative is risk assessment coordination.
In order to better focus its resources in food safety risk assessment
activities, FSIS established a risk assessment coordination team
with USDA-wide membership. The need for such a committee is growing
as risk assessment becomes more and more important as a means of
providing the science behind policy decisions. This group will promote
scientifically sound risk assessments and foster research to support
Microbial risk assessment is still in its infancy compared to chemical
risk assessments, so the need to share ideas and resources is even
more critical. In November 2003, we started this interactive process
- of sharing ideas and resources - by holding a public meeting to
discuss current government thinking and activities regarding how
the three components of the risk analysis framework (risk assessment,
risk management, and risk communication) are used to inform and
implement risk management decisions.
This was a very productive meeting, and we examined several crucial
factors including how:
- FSIS can improve the transparency of the risk analysis process;
- FSIS can balance the need for transparency, stakeholder involvement
and peer review with the need for timely scientific guidance;
- Risk assessments can better inform policy development and decision-making.
We are considering initiating risk assessments on Salmonella
in raw beef and poultry, and on the risk of Listeria monocytogenes
in packaged deli meat compared to that sliced at the retail level.
The latter is an effort that we must pursue, as we continue our
efforts to combat this pathogen. This assessment will help us determine
whether the risk lies with these products. It may well be that there
is still more that can be done at the processing plant, but it may
be that the area of focus may expand to what happens after the package
is opened and the product is further manipulated during meal preparation.
Our next initiative is developing a solid research agenda.
In November, FSIS and the Research, Education and Economics mission
area announced a unified research agenda to coordinate USDA food
safety research priorities and needs. Research is very important
for FSIS to achieve its public health vision. However, FSIS does
not conduct research itself, but it does have a role in identifying
its own research needs so that the research community can meet those
needs. The challenge for the future will be, like Dr. Pasteur strove
do to, transfer research results to practical use.
The fifth initiative is to develop a list of best practices
for animal production. In consultation with producers,
researchers, and other stakeholders, FSIS is developing a list of
best management practices for animal production in order to provide
guidance in reducing pathogen loads before slaughter.
Last September, we arranged a symposium to discuss ways to significantly
reduce the levels of E. coli O157:H7 in live animals before
slaughter. We understand that preventing the spread of E. coli
and other pathogens on the farm is vital to increasing food
safety and protecting public health. The dialogue that was generated
from that meeting was very beneficial toward our development of
guidelines outlining best management practices at the pre-harvest
stage, which we expect to publish this year. Once these guidelines
are developed, you can expect to see an aggressive outreach effort
by FSIS to distribute these to producers.
Another key initiative is to conduct baseline studies.
This is an absolute priority. We are in the final stages of reviewing
our protocols, and expect to begin a baseline study to determine
the nationwide prevalence and levels of various pathogenic microorganisms
in raw meat and poultry. We intend to conduct these studies on a
regular basis, if at all possible. The continual nature of the baseline
studies will provide both information on national trends as well
as a tool to assess performance of initiatives designed to reduce
the prevalence of pathogens in meat and poultry products. These
baseline studies will also provide important information for conducting
risk assessments that can outline steps we can take in reducing
Moreover, we will be able to correlate prevalence with practices
at processing plants, and thereby help us and you to better understand
what interventions are working, which ones are not, and if not,
why not. In the past, baseline studies have been used to establish
performance standards. Well, the new baseline studies will take
into account regional variation, seasonality and other critical
factors, which were not taken into consideration before, so they
will serve to give us the truest picture of prevalence we've ever
Achieving the Next Level of the Food Safety
The emergence of previously unrecognized pathogens, as well as
new trends in food distribution and consumption, highlights our
need for new strategies to reduce the health risks associated with
pathogenic microorganisms in meat, poultry and egg products. Through
analysis and discussions with stakeholders, we have identified three
issues that need to be addressed to attain the next level of public
The first issue is to anticipate/predict risk through
enhanced data integration. To better anticipate risks involving
meat and poultry products, we must have the best available data
to clearly identify the extent and nature of these risks, so that
we may determine an effective response. These data consist of regulatory
samples, as well as samples collected by food processing establishments.
Thus, there is a need to improve access to and analysis of food
safety data from all reliable sources. This is an area where the
assistance of groups such as NFPA is extremely important, and I
hope I can count on your support.
The second issue is the improved application of risk into
regulatory and enforcement activities. Food safety problems
need to be documented as they occur, so that conditions may be analyzed,
and if need be, corrected. A better understanding of the prevalence
and causes of food safety failures could allow better assessment
of how to best address them. Data regarding the causes of food safety
violations, either within a specific establishment, or within a
class, can be utilized in order to better focus prevention and regulatory
To develop a relative, real-time measure of how well an establishment
controls the biological, chemical, and physical hazards inherent
in its operations, FSIS is exploring the development of a Hazards
Control Coefficient (HCC). Imagine if we could divide the universe
of plants into categories based on the risk inherent in their product
(ground beef vs. beef jerky), and on the compliance history of the
plant, we could determine which plants have the lowest vs. the highest
probability of producing safe product. Such a scheme would help
the Agency make resource allocation decisions across this country's
more than 6,000 meat and poultry establishments based on risk, and
thus maximize food safety and public health protection.
Finally, the third issue is better association of program
outcomes to public health surveillance data. We have seen
notable advances in preventing foodborne illness, which CDC has
attributed in part to the implementation of HACCP. However, there
still is a need to determine how specific policies affect public
health. In order to accomplish this, data that links foodborne illness
outbreaks with specific foods needs to be obtained and documented.
It may then be linked with prevalence data of specific pathogens
in specific foods. However, to complete the linkage with public
health outcomes, a strong connection with human health surveillance
data is needed.
Accomplishing this task will help to point regulatory efforts toward
focusing its inspection and enforcement on those practices where
risk is deemed to be highest, resulting in a more efficient use
of government resources. Toward this goal, FSIS is working with
CDC's National Center for Infectious Diseases to design and support
studies that enable definite connections to be made between occurrence
of specific pathogens in specific foods and the occurrence of human
We are strengthening relationships with state health departments
to include attribution data in epidemiological investigations. We
are also examining the establishment of a joint task force with
CDC to determine ways to improve data collection by Food Net.
We intend to 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. It is our intention
to pursue such a course of action in as a transparent and inclusive
manner as possible. The resulting strategies should help USDA continue
to pursue its goals and achieve its mission of reducing foodborne
As we all know, protecting public health by ensuring safe and
wholesome food is not accomplished through one isolated action or
through just one organization. We are all in this together. We need
to challenge ourselves, challenge each other, and above all hold
ourselves accountable for improving food safety. The health of all
Americans relies partially on our continued cooperation and success.
All of us have to look at ourselves as public health stewards and
never rest in our mission to make the food supply even safer.
At times it may seem overwhelming to overcome the challenges we
face. However, Dr. Pasteur faced even greater hurdles and went on
to change the face of science, establish the discipline of microbiology,
and save lives through the application of his principles regarding
how "germs" can be eliminated. I know that by working together,
and keeping the big picture of public health in mind, we can succeed.
It has been a pleasure to be here with you today. I thank you for
your dedication and efforts, and I look forward to your continued
contributions in food safety. Now, I believe we have time for a