Fulfilling the Vision: Updates and Initiatives
in Protecting Public Health
Note: This mostly-text version is provided to ensure accessibility. A fully-illustrated, 28-page PDF version is also available.
Table of Contents
SECTION 1: Introduction
USDA's Food Safety and Inspection Service (FSIS) is a public health
regulatory agency charged with ensuring that the United States'
supply of meat, poultry, and egg products is safe, wholesome, and
correctly labeled. With the 2003 publication of "Enhancing
Public Health: Strategies for the Future," FSIS outlined five
goals it has been pursuing to improve the health status of consumers.
In that document, FSIS outlined a series of new and comprehensive
science-based initiatives to better understand, predict, and prevent
microbiological contamination of meat, poultry, and egg products,
thereby improving health outcomes for American families.
This document, titled "Fulfilling the Vision,"
evaluates the effectiveness of the implementation of these goals
and examines many specific outcomes associated with the initiatives
established in 2003. FSIS has also developed additional initiatives
to continue in its pursuit of improving food safety. One of the
improvements in food safety is the continued downward trend observed
over the last year in the presence of several persistent pathogens
in regulatory samples, including E. coli O157:H7, Listeria monocytogenes
and Salmonella, as well as a significant reduction in foodborne
We welcome the input of all interested parties to this document,
and encourage the exchange of ideas, as we move toward identifying
strategies and solutions that will further improve the safety of
the food supply for all consumers, both domestically and internationally.
SECTION II: Abstract
The Food Safety and Inspection Service (FSIS) is responsible for
ensuring that the commercial supply of meat, poultry, and egg products
moving in interstate commerce or exported to other countries is
safe, wholesome, and correctly labeled and packaged. In addition,
FSIS ensures that products imported from other countries are produced
by a system that is equivalent to that employed by FSIS.
FSIS is committed to improving public health through food safety.
In 2002, USDA's Office of Food Safety established five core goals
to improve food safety for American families. They continue to guide
the Agency's actions:
- 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.
Last year, FSIS outlined specific initiatives to fulfill these
goals and thereby improving health outcomes for American families.
These initiatives were reported in FSIS' food safety vision document,
Ensuring Public Health: a Vision for the Future. As part
of FSIS' continuing process to evolve, Fulfilling the Vision
was prepared as a detailed plan to best utilize Agency
resources and authorities to further enhance food protection systems
during the coming year.
In this document, FSIS presents a list of accomplishments achieved
over the past year that have enhanced the safety of our Nation's
food supply. In addition to these ongoing efforts, the emergence
of previously unrecognized pathogens, as well as new trends in food
distribution and consumption, highlights the need for new strategies
to reduce the health risks associated with pathogenic microorganisms
in meat, poultry, and egg products. Through analysis and discussions
with the scientific community, public health experts, and all interested
parties, issues have been identified that need to be addressed to
attain the next level of public health protection. A brief description
of these challenges is also presented in this document. The resulting
strategies should help FSIS pursue its goals and achieve its mission
of reducing foodborne illness.
SECTION III: Significant Food Safety
Significant food safety advancements have been made in the past
year. One of these has been improvements in implementation and verification
of plant Sanitation Standard Operating Procedures (SSOP) and Hazard
Analysis and Critical Control Point (HACCP) plans, leading to a
dramatic decline in the number of meat and poultry product recalls
during 2003. The number of Class I, or high risk, recalls in 2003
has nearly been cut in half from the total observed in 2002. In
the first half of 2004, the number of Class I recalls has decreased
even further to 16 at the time of this publication. This is a strong
indicator that the agency's scientifically based policies and programs
are working to prevent adulterated product from entering the marketplace.
Other indicators of success this past year include a trend of reduction
in pathogens found in meat and poultry regulatory samples. In late
2003, FSIS released data that showed, as of September 30th, a 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. We are cautiously optimistic that
this downward trend will continue, due to the regulation issued
in June 2003 for establishments producing ready-to-eat products
where Listeria monocytogenes is a concern. (More detail
on the reduction of this and other pathogens is found in the next
section of this document.)
More importantly, the accomplishments of our initiatives can be
observed in the annual (2004) report on the incidence of infections
from foodborne illness by the Centers for Disease Control and Prevention
(CDC). The report noted significant declines from 1996 to 2003 in
illnesses caused by E. coli O157:H7 (42%), Salmonella
(17%), Campylobacter (28%), and Yersinia (49%).
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, typically associated
with ground beef, dropped by 36%. This reduction in E. coli
O157:H7 illnesses brings the U.S. closer to achieving the “Healthy
People 2010” goal of 1.0 case per 100,000 people.
CDC attributes the changes in the incidence of these infections
to control measures implemented by government agencies and the food
industry, and enhanced food safety education efforts. Specifically
with regard to E. coli O157:H7, CDC attributes the reduction in
illness caused by this pathogen to policies implemented in 2002
and 2003 by FSIS.
Basing Policies on Science
Data gathered during an outbreak of Listeria-related illnesses
during the summer/fall of 2002, combined with other food safety
investigations and in-depth verification reviews, led FSIS to conclude
that some establishments were not adequately addressing the potential
for bacterial contamination in their HACCP plans, SSOP, or other
control measures. As an interim measure, FSIS implemented a directive
in December 2002, outlining steps to be taken by USDA inspectors
to ensure that establishments producing ready-to-eat (RTE) meat
and poultry products were preventing Lm contamination. The Lm
directive was an aggressive and targeted approach to further reduce
the risk of listeriosis from consumption of high- and medium-risk
RTE products. This directive subjected establishments to intensified
verification testing if they produced high and medium- risk RTE
meat and poultry products (deli meats and hot dogs) without validated
controls for preventing Lm, or if they failed to share
information related to such programs with FSIS.
In February 2003, FSIS released a draft scientific risk assessment
on Listeria in RTE meat and poultry products. A public meeting was
held on February 26, 2003, to discuss the risk assessment. The risk
assessment, in conjunction with a previously released FDA/FSIS risk
ranking and public comment gathered on the topic and a peer review
of the risk assessment, provided important data enabling FSIS to
design a final Lm rule.
On June 6, 2003, FSIS issued an interim final rule requiring Federal
establishments producing certain RTE meat and poultry products to
take steps to reduce the incidence of Lm. Under the rule,
establishments choose one of three approaches based upon the stringency
of the control program for Lm that they implement. The
approach taken is one factor in determining the frequency of FSIS
conducted verification activities in each establishment, with the
highest frequency concentrated in establishments that rely solely
on sanitation practices, compared with those that implement more
aggressive and effective strategies, such as incorporating an inhibiting
agent in product formulation or inserting an additional processing
step to kill pathogens that may contaminate the product after cooling.
The rule became effective on October 6, 2003, and the Lm
directive was updated to reflect the policies outlined in the rule.
FSIS is accepting comments about the rule for 18 months after publication
for the purpose of reviewing and evaluating the effectiveness of
The Listeria rule was built upon the results of the very
thorough quantitative risk assessment, which provided guidance about
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 could contaminate
product. Most meaningfully, the risk assessment showed that an establishment
could choose the most effective strategy to control Listeria
depending on its product(s) and the environment in which it operates.
The Listeria rule's impact has already been significant
in terms of the changes that establishments have made to prevent
product from harboring this organism. FSIS recently conducted a
survey of its inspection personnel in 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. More than 57%
started testing for Listeria in the plant environment,
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. This rule challenged industry to do more to prevent
contamination with this pathogen.
Escherichia coli O157:H7
Agency measures to prevent ground beef contaminated with
E. coli O157:H7 from entering commerce have also yielded
significant decreases in this pathogen. FSIS declared E. coli
O157:H7 an adulterant in raw ground beef in 1994. Over the
last decade, FSIS has undertaken a number of initiatives to reduce
the prevalence of this pathogen in raw ground beef. Beginning in
October 2002, FSIS required that each plant producing raw beef products
reassess its HACCP plan in order to ensure product contaminated
with E. coli O157:H7 does not enter commerce. Scientifically
trained FSIS personnel then conducted the first-ever comprehensive
audits of 1,500 beef establishments' HACCP plans. Sixty-two percent
of those plants made major improvements based on these reassessments,
and 60 percent added E. coli O157:H7 as a pathogen likely
to occur. As a result, we are seeing a significant drop in the percentage
of E. coli O157:H7 positive regulatory samples in ground
In September 2003, FSIS released data collected from January 1
through August 31, 2003, showing a drop in the number of E.
coli O157:H7 positive samples of ground beef that FSIS had
collected, compared with past years. Of these samples, 0.32 percent
tested positive for E. coli O157:H7, a decrease from 0.78
in 2002 and 0.84 in 2001, and 0.86 in 2000. Since 2001, FSIS has
analyzed approximately 7,000 samples annually.
In addition, the agency has taken steps to begin a science-based
baseline study for trimmings used to make raw ground beef, the design
of which was reviewed by scientists serving on the National Advisory
Committee on Microbiological Criteria for Foods (NACMCF).
A directive was issued in May 2004 to provide new instructions
to inspection program personnel for collecting samples for E.
coli O157:H7 testing. The directive provides new instructions
for follow-up actions that FSIS personnel will take after an initial
FSIS sample of raw ground beef product, raw ground beef components,
or raw beef patty components tests positive for E. coli
O157:H7. It also provides new instructions to inspection program
personnel for verifying the control of raw beef products that are
"positive" and "presumptive positive" for E.
coli O157:H7 and that are moved to another official establishment,
landfill operation, or renderer for proper disposal.
Under the new directive, 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 than other establishments.
In addition, FSIS will weigh its 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. In the future,
FSIS intends to develop a random sampling and testing program for
raw ground beef components and beef patty components and non-intact
beef products other than ground beef, such as mechanically tenderized
and injected steaks and roasts.
FSIS is considering how best to ensure that its inspectors are
aware of, and have access to, the results of testing done by establishments.
FSIS is considering whether some mechanism beyond discussing test
results at the weekly meeting is necessary.
FSIS' Office of Program Evaluation, Enforcement and Review (OPEER)
plans to conduct an internal audit to determine the effectiveness
of the new policies which have been designed to reduce the incidence
of E. coli O157:H7.
A little over a year ago, FSIS also issued new procedures for utilizing
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 SSOP and HACCP plans, reviews are initiated after any series
of tests fails to meet a standard. Improvements to the in-depth
review process have also been implemented, such as the inclusion
of Enforcement, Investigative Analysis Officers and other HACCP-trained
personnel. This process and other science based initiatives, including
strategies implemented to reduce E. coli O157:H7, have
played a significant role in reducing the prevalence of Salmonella
in raw meat and poultry regulatory samples. 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.
Although the agency's rate of positives in regulatory samples of
all three pathogens discussed may not represent the prevalence of
these pathogens nationwide, it is indicative of a statistically
significant downward trend.
Bovine Spongiform Encephalopathy (BSE)
The agency demonstrated its responsiveness in the immediate aftermath
of the BSE discovery in Washington State in December
2003 by further strengthening existing BSE detection and prevention
Ban on Non-Ambulatory Disabled Cattle. Cattle.
On December 30, 2003, Secretary Ann Veneman announced a ban on all
non-ambulatory disabled cattle from entering the human food supply.
FSIS' Public Health Veterinarians, or PHVs, are responsible for
enforcing this ban.
New Regulations Issued. Following the Secretary's
immediate ban on all non-ambulatory disabled cattle, FSIS issued
four Federal Register documents to further enhance safeguards to
prevent BSE from entering the food supply. The regulations and policies
set out in these documents add a significant level of protection
to an existing strong food safety system. They also are generally
consistent with those taken by Canada after the discovery of a BSE
cow there in May 2003.
- The first document was a notice that announced
that FSIS inspectors will no longer mark cattle tested for BSE
as inspected and passed” until confirmation is received
that the cattle were negative for BSE. This notice was designed
to prevent the entry of positive animals into the food supply.
- In the second document, an interim final rule,
FSIS declared that skull, brain, trigeminal ganglia, eyes, vertebral
column, spinal cord and dorsal root ganglia of cattle 30 months
of age or older, and the small intestine and tonsils of all cattle
are specified risk materials (SRM) and that these materials were
unfit for food. These enhancements are based on conclusions drawn
by the World Health Organization which state that "removal
of visible nervous and lymphatic tissue from meat can provide
reassurance" that BSE will not be transmitted.
- The third document was an interim final rule
on advanced meat recovery (AMR). This rule prohibits the use of
the vertebral column, skull, dorsal root ganglia, spinal cord
tissue or any other SRM in AMR.
- The fourth document was an interim final rule
that bans the practice of air-injection stunning. This was done
to ensure that
portions of the brain are not dislocated into the tissues of the
carcass as a consequence of stunning cattle during the slaughter
process. While the use of this type of stunning device is not
common in the U.S., officially banning its use not only
ensures that it will be prohibited domestically, but will also
make it a requirement for equivalency in foreign establishments
that export meat into the U.S.
The three interim final rules became effective on January 12,
2004. There was a significant comment period allotted for each
of the final interim rules, and the agency has received approximately
22,000 comments. These are being reviewed to determine if any
changes are warranted.
Participation in BSE Surveillance. The Animal
and Plant Health Inspection Service (APHIS) at USDA began an enhanced
animal surveillance program for BSE in June of 2004. FSIS PHVs will
collaborate with APHIS by collecting brain samples from cattle that
are condemned during ante-mortem inspection at federally inspected
establishments. Specially trained PHVs will collect the brain samples.
The samples will be shipped to the National Veterinary Services
Laboratory (NVSL) in Ames, Iowa,
or another USDA designated laboratory.
FSIS inspectors are responsible for making the critical decisions
in order to ensure the safety of meat, poultry, and egg products.
Thus, it is essential to have a workforce that is well trained in
the science of food safety, using modern methods
in order to enhance effectiveness of training. With a workforce
numbering approximately 10,000 people, training all employees is
a considerable undertaking. FSIS has made a positive start in this
effort and will work to train more of its workforce in the coming
In April 2003, FSIS inaugurated a new Food Safety Regulatory Essentials
(FSRE) training program, which is designed to better equip inspection
personnel in verifying an establishment's HACCP food safety system.
All students receive training in the fundamentals of inspection,
covering the Rules of Practice, Sanitation Performance Standards,
and Sanitation Standard
Operating Procedures (SSOP). Customized HACCP training is then provided,
based on the types of products, raw, ready-to-eat, or shelf stable,
being produced at the establishments where inspectors are assigned.
More than 1,500 FSIS employees will receive FSRE training in 2004,
with an additional 1,000 slated to complete this customized job
training regime in 2005. Also in 2003 and 2004 over 200 Consumer
Safety Officers, Public Health Veterinarians, and Compliance Officers
received Enforcement Investigative and Analysis training. This training
focuses on enacting and documenting administrative enforcement
action in cases involving violations of food safety requirements.
In August 2003, FSIS announced that employee training would be
made more accessible through the establishment of five new regional
training sites: Atlanta, Dallas, Philadelphia, Des Moines, and Boulder.
Towards this end, FSIS has recently assigned public health training
coordinators to the Des Moines, Philadelphia, Dallas, and Atlanta
training centers to move training closer to employee worksites and
enable us to reach more of our workforce.
During 2004, FSIS trained 140 frontline supervisors in supervision
and management of the verification of food safety systems. Also,
FSIS has begun to train all new entry-level slaughter establishment
inspectors and PHVs in technical, regulatory, and public health
methods. The plan is to train 1,200 employees in 2005. FSIS is planning
to expand the types of training in
the future to meet evolving agency needs and challenges. Also in
2004, FSIS has implemented a sophisticated food security awareness
training for employees. This training has been provided to 4,000
agency employees. This comprehensive two-year training and education
effort is designed to ensure that every FSIS employee fully understands
his or her role in preventing or responding to an attack on the
For the 2005 fiscal year, FSIS has requested over a 50-percent
increase in the FSIS training budget. These funds are essential
so that FSIS can continue to provide vital scientific and technical
training to its workforce to protect public health. New employees
will now be required to demonstrate mastery of training in order
to be certified to assume inspection duties. Additional funds have
also been requested to supplement the training for other current
field employees to improve enforcement of Hazard Analysis and Critical
Control Point/Pathogen Reduction regulations and food safety sampling.
The additional funding
will also be used to expand the agency's regional training capabilities
to reach the workforce with training to address emerging
"This Administration remains committed to improving
our meat inspection systems. Training for inspectors is an important
part of our efforts to ensure that all our systems effectively
protect the public health."
Agriculture Secretary Ann M. Veneman.
In August 2002, FSIS created the Office of Food Security and Emergency
Preparedness (FSIS-OFSEP), which assumed the responsibilities of
F-BAT to serve as the centralized office within the agency on food
security issues. FSIS-OFSEP is charged with developing the agency's
infrastructure and capacity to prevent, prepare for, and respond
to actual or suspected deliberate
and unintentional, but major, events that threaten the U.S. food
supply. FSIS-OFSEP is the lead coordinator and primary point of
contact on all food security activities within FSIS and USDA. FSIS'
homeland security activities have focused on
In November 2003, FSIS issued the booklet Food Safety and
Food Security: What Consumers Need to Know at
the American Public Health Association's annual convention, one
of the largest gatherings of public health officials in the world.
In addition, USA Today featured a news story on the importance of
the information found in this booklet. These consumer guidelines,
available in English and Spanish, offer comprehensive and practical
information about safe food handling practices, foodborne illness,
keeping foods safe during an emergency, and how to report suspected
instances of food tampering.
To ensure the safety of imported products from intentional contamination,
since March 2003, FSIS has trained and deployed 20 new Import Surveillance
Liaison Inspectors (ISLIs) to augment the efforts of traditional
FSIS inspectors assigned to 146 Import Houses around the country.
ISLIs conduct additional surveillance activities at each import
facility and at locations outside the facilities where imported
product may enter or be stored. They also work to improve coordination
with other agencies, such as APHIS and the Departments of Homeland
Security and Health and Human Services, which share the responsibility
of ensuring the safety of imported food products.
FSIS has also made important security progress on the scientific
front. FSIS laboratories have expanded their capability to test
for non-traditional microbial, chemical, and radiological threat
agents. Construction on a Biosecurity, Level-3 laboratory was completed
and the laboratory opened in April 2004. The Biosecurity, Level-3
Laboratory will enable FSIS to conduct analyses on a larger range
of potential bioterrorism agents.
The agency also has played a lead role in the development of the
Food Emergency Response Network (FERN). Working in collaboration
with the Food and Drug Administration (FDA), the Centers for Disease
Control and Prevention (CDC), the Environmental Protection Agency
(EPA), the Department of Energy (DOE), and the States, this network
integrates the Nation's laboratory infrastructure and surge capacity
at the local, State, and Federal levels. Currently, over 60 laboratories
(including public health and veterinary diagnostic laboratories)
representing 27 States and 5 Federal agencies have agreed to participate
in FERN. The network's primary focus is on method validation, research,
training programs, proficiency programs, surveillance, response
and surge capacity, and communication in preparation for and response
to a potential attack on the food supply. By providing a greater
capability to test for biological, chemical, and radiological agents
in food, FERN will provide the Nation with a strong scientific infrastructure
to protect the food supply. The FERN Steering Committee is also
working to establish five Regional Coordination Centers that will
serve as the primary points of contact for laboratories in the region.
Two of the FERN Regional Coordination Centers are already in operation.
FSIS also plays a key role in the Electronic Laboratory Exchange
Network (eLEXNET), a pilot Web-based
data exchange system. eLEXNET is currently comprised of 100 participating
labs on the Federal, State, and local levels. eLEXNET feeds into
FERN and is used as one of their data-capturing mechanisms. eLEXNET
can also act as a data-capturing mechanism, and is building the
capability to handle sensitive food analyses.
FSIS has signed an agreement with the Army facility at Aberdeen-Edgewood
in Maryland under which Aberdeen will accept and analyze high-risk
samples for the presence of a variety of biological agents when
necessary. Similarly, FSIS signed a Memorandum of Understanding
with FDA on January 22, 2004, whereby HHS-FDA will test meat, poultry,
and egg products
for very low levels of radiological contamination, as necessary.
Finally, to ensure that laboratories as well other offices are
secure, the agency hired a Physical Security Specialist in June
2003 to assess the security of FSIS sites and develop internal policies
to enhance security of the Agency's personnel and property.
Strengthening Oversight of Recalls
Product recalls are conducted by establishments, either on their
own initiative, or as a result of a recommendation made by FSIS.
This occurs when there is reason to believe that product that is
adulterated or misbranded has entered commerce, or when it has been
linked to a foodborne illness outbreak.
In order to improve the effectiveness of product recalls, FSIS
issued revised Directive 8080.1, "Recall of Meat and Poultry
Products." The changes to the directive are designed to enhance
the instructions and guidance to agency personnel responsible for
verifying that activities necessary to conduct a recall are performed
quickly and efficiently. The agency is also increasing the number
of effectiveness checks that it carries out during Class I recalls
(those posing the greatest potential adverse health
consequences). Effectiveness checks are designed to ensure that
proper notification has been given from the supplier to all consumers,
including retail establishments, and that product that is retrieved
is accounted for and properly disposed of. The revised directive
includes timeframes for reporting verification activities within
FSIS and includes provisions for locating products at point of sale.
In an effort to enhance the effectiveness and expediency of the
recovery of products involved in a recall, FSIS is exploring possibilities
for providing additional information to the public about the distribution
of the recalled product. The agency is considering whether additional
information can be provided while still preventing the disclosure
of proprietary information and
preserving the confidential nature of the establishment's business
Modernization of Enforcement Activities
In order to modernize the agency's enforcement activates, FSIS
created the Office of Program Evaluation, Enforcement, and Review
(OPEER). This office consists of staffs and divisions previously
scattered throughout the agency. These were merged to enhance the
agency's evaluation, review, assessment, investigation, enforcement,
and audit capacity to thus improve food safety, food security, management
effectiveness, efficiency, and decision-making at the Administrator's
OPEER is responsible for managing and directing investigations,
case development, and documentation of violations of FSIS' laws
and regulations. It (1) provides guidance and direction relating
to transportation, storage, distribution, and marketing of food
products in commerce; (2) monitors State compliance and enforcement
programs; (3) monitors and controls regulated
products in commerce; and (4) works with OIG and other regulatory
and law enforcement authorities in investigations of violations
of laws and regulations.
OPEER's Enforcement and Inspection Officers can more accurately
and consistently identify and document violations through the use
of the recently developed Administrative Enforcement Report, which
establishes methodologies and protocols that enhance inspection/enforcement
activities. A new internal audit process has been put in place as
a proactive measure to
identify and review any existing or anticipate any possible future
problems that could result from corrective enforcement action. This
audit process provides the necessary checks and balances to ensure
that enforcement procedures are applied more consistently at the
OPEER is also conducting independent monitoring in commerce activities
of the new BSE surveillance program and food security surveillance
of products in distribution. In sum, OPEER' role in examining agency
problems and issues, and work with agency leadership in developing
policy changes and improvements is both critical and profound. Future
work will include numerous audits, investigations, evaluations or
reviews of many key policies and programs.
Strengthening State Reviews
Under the Federal Meat Inspection Act (FMIA) and Poultry Products
Inspection Act (PPIA), the United States Department of Agriculture
(USDA)/FSIS has clear responsibility for setting a national standard
for meat and poultry inspection. Under a cooperative agreement with
FSIS, States may operate their own programs if they meet and enforce
requirements at least equal
to those of the Federal program. States may enter into a cooperative
agreement for meat inspection, poultry inspection, or both meat
and poultry inspection. FSIS is required to monitor State programs
and to assume direct responsibility at State plants when a State
fails to develop or effectively enforce inspection requirements
that are "at least equal to" Federal requirements. To
date, 28 States have State programs that operate under a cooperative
agreement with FSIS.
Due to heightened security concerns after September 11, 2001,
increased agency emphasis on review of all FSIS programs and
activities, and the 2002 Farm Bill, FSIS began comprehensive reviews
of State meat and poultry inspection programs. In 2003, the agency
undertook a series of actions to update and strengthen its policies
and procedures for reviewing State meat and poultry inspection (MPI)
The new comprehensive State review process has two parts. First,
each State performed a self-assessment that was submitted to FSIS
for review. Second, on-site visits began last fall to determine
whether the States are maintaining "at least equal to"
programs. FSIS randomly selected four State programs - Kansas, Mississippi,
Missouri, and Wisconsin - for on-site reviews. Multi-disciplinary
review teams conducted on-site verification reviews in State offices,
laboratories, and a sample of establishments. All 28 State programs
will eventually have an on-site verification review.
Best Practices for Animal Production
In consultation with producers, researchers, and other stakeholders,
FSIS has recently developed guidance which suggests management practices
for animal production geared to reducing pathogen loads before slaughter.
Last September, the agency arranged a public symposium to discuss
ways to significantly reduce the levels of E. coli O157:H7
in live animals before slaughter. The dialogue that was generated
from that meeting was very beneficial toward our development of
guidelines outlining best management practices at the pre-harvest
Preventing the spread of E. coli O157:H7 and other pathogens
on the farm is vital to increasing food safety and protecting public
health. There are several promising avenues of research including:
antibiotics and probiotics, vaccines, sodium chlorate and bacteriophages.
FSIS is closely following research development and will encourage
the use of interventions as they are
Producers can take several steps to improve public health through
the adoption of on-farm best practices that focus on reducing pathogens
and fecal coliforms in feed and water and ensuring the proper handling
of manure. Feedlot best practices set up multiple barriers for enteric
pathogens by providing safe feed, clean water, and proper manure
disposal, thus helping to reduce pathogen loads pre-harvest and
reducing the prevalence of E. coli O157:H7 in cattle.
FSIS will conduct an aggressive outreach effort to distribute
these guidelines to producers in the coming months.
International Food Safety
Food safety and security do not stop at national borders. With
the global food supply, countries are interdependent. The way food
is traded has a tremendous impact on the health of populations.
Increasing international trade has meant that a greater variety
of foods are available to the world's population. However, this
expansion in food distribution also means that a
greater probability exists for unsafe food to reach a large population.
The importance of international food safety led to the creation
within the Food Safety and Inspection Service of the Office of International
Affairs, which reports directly to the administrator of the Agency.
This office brings together all of the agency's activities related
to imports, exports, multi-lateral initiatives, and the Codex Alimentarius
Commission. This office is
implementing the agency's increased emphasis on international food
safety in a number of ways:
First, harmonizing international food safety standards to the
extent possible is an important way to improve food safety globally,
particularly in developing countries that need assistance in enhancing
the quality of their food safety systems. Thus, the United States
is very active in the Codex Alimentarius Commission, which is the
major international mechanism for developing international food
safety standards. The office of the U.S. Codex Manager resides within
FSIS, and reports to both the
Agency Administrator and the Under Secretary for Food Safety. The
latter chairs an interagency committee that develops U.S. policies
in food safety, which are presented at Codex meetings. FSIS encourages
groups representing industry and consumers to become more involved
in Codex, and the agency is engaged in an aggressive outreach program
to encourage and assist other countries in participating effectively
in the Codex Alimentarius Commission activities.
Another way FSIS ensures the safety of foods traded globally is
through the agency's import inspection system. FSIS has jurisdiction
over meat, poultry, and processed eggs products, and FDA has jurisdiction
over all other foods. However, there are
differences in the import inspection requirements demanded by FSIS
compared with those required by FDA. FDA's inspection requirements
are company specific, and the agency relies on point-of-entry inspections
for all products that are under its
jurisdiction. By contrast, instead of interacting directly with
individual companies, FSIS deals with the central competent authority
within a country before accepting meat or poultry products from
that country for sale in U.S. commerce.
FSIS uses a multi-step process to determine whether another country's
food regulatory system is equivalent to U.S. standards and the country
is eligible to export to the United States. First, the country's
laws regarding food safety and its
sanitary measures are examined. Second, a multidisciplinary team
of FSIS food safety experts visits the exporting country to conduct
an on-site audit to verify that the country has satisfactorily implemented
all laws, regulations, and other requirements. In addition, the
FSIS OPEER office conducts an independent review of these findings.
FSIS does not conduct food inspections in other countries, nor
does the agency certify individual foreign establishments for export
to the United States. After it has been determined that a country
has an equivalent food regulatory system, FSIS relies on that system
to carry out daily inspection.
On-site food regulatory system audits are conducted at least annually
in each country that exports meat or poultry to the United
States. Finally, FSIS has continuous port-of-entry reinspection
of products shipped from exporting countries at 146 Import Houses
across the country. These reinspections provide verification that
the exporting country's inspection system is functioning well.
FSIS also plays a critical role in ensuring food safety is a key
aspect of global trade negotiations and that international science-based
standards enhance global public health. In 2003, the Chile Free
Trade Agreement (FTA) was signed, and critical decisions were also
reached on the Central American Free Trade Agreement (CAFTA), which
comprises the countries of Costa Rica, Nicaragua, Honduras, El Salvador,
and the Dominican Republic. The Chile FTA included the acceptance
by Chile of the systems recognition approach explained above. This
approach was advanced by the U.S. trade negotiators and considered
crucial by U.S. producers and exporters to realize potential market
USDA recently entered into a Memorandum of Understanding (MOU)
with the Pan American Health Organization (PAHO) to establish ways to improve
the safety of meat and poultry products that are traded among the
nations of the Western Hemisphere. USDA and PAHO currently collaborate
on several projects through strategic alliances to increase and
improve food safety, animal health and trade. The MOU is effective
immediately and will be in place for the next three years.
Food Handler Education and Outreach
FSIS consumer education programs are modeled on the marketing concept
of "integrated marketing" which has three components,
each of which supports the other:
- mass media--reaching out to the broad public,
- cluster targeting--utilizing demographic, geographic, and socio-demographic
information to target communications to segmented audiences, and
- one-on-one interactions, especially through the USDA's Food
Safety Mobile, expanding outreach programs to include
new services and partnerships for minorities and underserved populations
both in the U.S. and abroad.
Each component of the integrated marketing program is developed
based on risk research, delivered utilizing social marketing concepts,
and assessed through evaluative research. Ongoing nationwide surveys
and consumer focus group studies are used to evaluate and ensure
the continuing effectiveness of the initiative and to continue to
track the documented changes in consumer behavior.
One such initiative currently planned is a targeted thermometer
education campaign in the State of Michigan during August 2004.
FSIS is working with the National Food Safety and Toxicology Center
from Michigan State University, along with local partners, to host
events in 3 cities: Ann Arbor, Lansing, and Grand Rapids. The goal
is to increase the use of food thermometers and prevent foodborne
The initiative will use social marketing principles to promote
positive behavior change. The target audience will be a selection
parents of young children under age 10, chosen as most likely to
change behavior. Before-and-after testing will be conducted by Michigan
State University and an overall evaluation will be conducted in
collaboration with USDA to assess the effectiveness of this effort.
This pilot will be a role model for other States and may serve as
the basis for a possible national launch of this initiative in 2005.
FSIS is committed to communicating with all food handlers, especially
those who serve others in large-scale food operations, or are personally
at-risk for foodborne illness. The agency has made great strides
in reaching out to citizens who may not speak English. Food safety
publications for both industry and consumers have been translated
into several languages including
Spanish, Korean and Mandarin Chinese. The agency utilizes national
television, cable networks, educational television, radio, magazines,
newspapers, and Web sites to enhance public education efforts.
In January of 2004, Agriculture Secretary Ann M. Veneman announced
an aggressive program to enhance USDA's electronic government capabilities
as part of President Bush's Management Agenda. The agency responded
to the challenge by expanding its reach to consumers through cyberspace.
In April of 2004, FSIS launched its newly designed, customer-focused
Web site to help make finding information about food safety easier
and faster by providing continuous, uninterrupted global capabilities
around the clock. The redesigned FSIS Web site was the first of
the Department's agencies to debut as part of the Secretary's initiative.
The revamped Web site provides the latest information about food
safety with an innovative twist. Consumers can communicate with
"Karen," the FSIS virtual representative. "Karen"
can answer questions about safely storing, preparing, and handling
poultry, and egg products. "Karen" instantly can respond
to questions originating from anywhere in the world. (Of course,
consumers can also still call the USDA Meat and Poultry Hotline,
1-888-MPHotline (1-888-674-6854) with questions.)
Ensuring that meat, poultry and egg processing plants understand
the agency's directives and regulations is a key aspect of the agency's
outreach program. The agency has recently initiated a series of
teaching workshops designed to provide owners and operators of plants
with detailed information about new directives as well as updated
procedures inspectors will follow in verifying plant compliance
in several areas. Workshops have been held across the country on
such topics as Listeria monocytogenes, BSE, and E.
coli O157:H7. Over 1000 attendees have benefited from these
interactive sessions. The information from these workshops is available
upon request, in both English and Spanish.
SECTION IV: Achieving the Next Level
of Food Safety
"Food safety is too important to be left to guess work
or luck; we must be prepared to identify and meet challenges head
on. We still have room for improvement in lowering foodborne illness,
and it takes all parties, from all backgrounds in the farm-to-table
chain to take responsibility and work together to ensure that
our food supply continues to be the safest in the world."
Dr. Elsa Murano, Under Secretary for Food Safety
The first challenge is the need to anticipate/predict
risk through enhanced data integration. FSIS is engaged
in developing innovative ways to anticipate hazards, so that it
can act to ensure that those hazards do not manifest themselves
as public health problems. One significant way in which this can
be accomplished is by thoroughly analyzing data obtained from FSIS'
regulatory sampling, as well as other sources of data, so as to
discern trends and identify connections between persistence, prevalence
and other factors, such as practices employed at plants, seasonal
variations, and size of establishment.
Currently, the agency is examining its regulatory data to identify
conditions that consistently have presaged the development of significant
problems. A goal is to have inspection personnel utilize these data
on a regular basis so that they can make decisions and inform the
establishment in order to have them take corrective action that
may prevent a problem. Including data collected by the establishment
would add robustness to the information and would improve the quality
and validity of conclusions made. This would contribute to enhanced
actions that could truly prevent problems.
A second assessment tool that the agency is developing to help
its inspection personnel anticipate problems is a hazards guide.
The agency has a contract with a vendor for the development of this
guide, which will assist inspection personnel in delineating the
hazards associated with a particular process (rather than a product),
and to assess whether the establishment is addressing that hazard.
The agency intends to ensure that relevant data such as the results
of the agency's investigations of recent outbreaks, and the agency's
conclusions about the products involved, is included, in addition
to other data. The guide will help inspection personnel divide an
establishment's operation into its component processes and to analyze
the establishment's approach to each process. The ability to do
so should enable inspection personnel to more effectively evaluate
the establishment's hazard analysis. It will give them the means
with which to assess whether the establishment is correctly identifying
the hazards that may occur in its operation and is addressing those
that are reasonably likely to occur.
A third assessment tool that the agency is considering is to establish
new performance standards. These standards could be developed based
on baseline studies which the agency is scheduled to begin this
summer, or, as the National Advisory Committee on Microbiological
Criteria for Food (NACMCF) has stated, existing agency data. One
approach is to establish performance standards that are informal,
rather than regulatory standards like the Salmonella standards
that the agency adopted in 1996. As guidelines, the agency could
use the performance standards as benchmarks to determine whether
establishments are appropriately controlling pathogens in their
operations. While there would not be formal regulatory consequences
for failures, a failure would provide an indication that the agency
needs to take a closer look at the establishment through in-depth
verification reviews, which could result in regulatory action. Because
the performance standards would only be guidelines, the agency would
be free to change them, either in response to a new baseline or
other newly available data, or to modify the point at which the
agency would consider a food safety assessment warranted, without
having to conduct a lengthy process. This would add flexibility
and speed to the agency's ability to change the guidelines according
to new data, which would provide a much more scientifically accurate
trigger for conducting in-depth verification reviews. FSIS will
continue to explore this and other approaches to performance standards.
FSIS has innovative initiatives underway to provide it with tools
that will enable it to anticipate risk. However, ensuring the availability
of data to FSIS from industry, academia, States, consumers, and
foreign countries will be necessary if the agency is to maintain
the currency of these tools.
One way that this can be accomplished is through the establishment
of a third-party data repository. This could be done through a contract
with an academic institution in such a way as to protect the integrity
of the data, while providing the confidentiality to industry that
would be required in order to ensure that no consequences would
be derived from sharing plant data with FSIS.
FSIS recently asked the National Advisory Committee on Meat and
Poultry Inspection (NACMPI) how the agency can ensure ready access
to data from all relevant sources, including consumer groups, the
States, and foreign countries. Several suggestions emerged from
the group's deliberations and recommendations:
- The Committee suggested that FSIS provide the public with information
on how it would like to receive data that is voluntarily submitted.
For example, given the fact that data could be used against a
company that is the source of the data, the agency should define
the circumstances in which it would consider anonymous data useful.
The agency should address whether the removal of identifiers would
be acceptable, and whether it would accept aggregate data.
- The Advisory Committee suggested a public meeting to discuss
the ground rules for agency access to data. The Advisory Committee
also suggested that public meetings would be useful on specific
matters on which FSIS needs data.
- The Committee also suggested that the agency make greater use
of the correlations that were done in-plant by the Technical Service
Center. The Advisory Committee stated that the results of these
correlations might point to conditions that were predictive of
more significant problems.
- The Advisory Committee suggested that FSIS conduct event analyses
of significant problems. The analyses would explore why the event
occurred, why it occurred in the particular establishment involved,
and what could have been done to prevent it.
The agency is currently examining these and other options, in order
to determine the course of action that will best enable it to anticipate
risk, and thereby protect public health.
The second challenge is the need for 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 corrected as appropriate. A better
understanding of the prevalence and types 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 of establishments, can
be utilized in order to better focus our attention where the risks
are greatest. In addition, it can provide us a tool to determine
enforcement trends by district and by circuit, which supervisors
can use to determine whether enforcement actions are being consistently
FSIS has developed, and is beginning to field-test, a "real-time"
measure of how well establishments control the biological, chemical,
and physical hazards inherent in their operations. This measure,
the Hazard Control Coefficient (HCC), uses both in-plant and laboratory
inspection and verification findings from an establishment during
the past 6 months to quantify the level of compliance with regulatory
requirements. HCCs are computed so they range from 0 to 20, with
lower HCCs indicating fewer deviations from regulatory requirements.
HCCs are updated monthly using the most recent 6 months of agency
data, and are used as a management tool.
Thus, HCCs could be assigned to each meat, poultry, and egg processing
plant in the U.S., allowing FSIS to divide them into groups, according
to how well each is complying with agency regulations.
HCCs are still in a developmental phase, and so a field-test has
begun that involves monthly transmission of the HCCs to District
Inspection Coordinators for the establishments in their own districts.
These transmittals to a given district office commence only after
one or more headquarters personnel, with thorough conceptual and
computational knowledge of the HCC, visit that office to explain
what HCCs are, how they are computed, and how they can be properly
interpreted. The primary purpose of the field-test is to obtain
input from the district office personnel on how HCCs might be improved
so they can be a more useful management tool. How HCCs are actually
computed, however, will not be revised without due input from senior
HCCs have the potential to help the agency better focus its activities
across this country's more than 6,000 meat and poultry establishments
based on how well they control hazards, thereby improving food safety
and public health protection.
In conjunction with HCCs, the agency has developed the concept
of a Hazard Coefficient (HC). HCs are measures of the inherent hazards
in federally inspected meat and poultry establishments, based on
the species of animal slaughtered or processed in the establishment,
the types of products that the establishment produces, and the establishment's
production volume. HCs were recently used to help prioritize E. coli
O157:H7 reassessment efforts.
Just like HCCs, HCs could be assigned to each meat, poultry, and
egg processing plant in the U.S. Combining HCC and HC data would
enable the agency to determine which establishments producing low-versus
high-risk products are best able to control hazards. This structure
could serve to develop a strategy by which plants in need of attention
would be identified, thereby ensuring better use of agency resources.
Similar to the HCC and HC concepts, the agency is also beginning
an effort to develop Food Security Risk Coefficients (FSRCs). FSRCs
will be numerical indicators of how well operators of federally
inspected meat and poultry
establishments protect themselves from the intentional introduction
of hazards into their products. FSRCs are designed to indicate the
possibility of problems if establishments are not doing a good job.
The data for the FSRCs will come from a survey
of Inspectors-in-Charge (IICs) to be administered by the agency
in the near future. Survey questions will be constructed from a
number of sources, including from the FSIS Security Guidelines for
Food Processors published in May 2002.
A predictive model to help with resource allocation decisions
The agency uses in-depth verifications and other food safety assessments
to examine an establishment's HACCP system, or some narrower aspect
of the establishment's operation, to determine what factors contributed
to the food safety problems that have occurred. FSIS is revising
the directives on food safety assessments to clarify the purposes
behind these investigations and to tailor the assessments so that
they are best able to achieve their purposes. For example, FSIS
is attempting to develop a methodology specifically designed to
find the source of E. coli O157:H7 problems and to provide
the basis for enforcement actions that focus specifically on these
problems. Moreover, the agency is conducting a review of the numerous
assessments that have been conducted to date, in order to determine
whether any conclusions or principles can be extracted that may
be useful in developing future strategies.
To ensure that food safety problems are appropriately documented
when they occur, the agency has developed, and now is endeavoring
to improve, the administrative enforcement report process (AER).
This process helps ensure that regulatory actions are as well grounded
as possible in the facts of an incident and in the applicable statutory
The agency's Office of Program Evaluation, Enforcement, and Review
(OPEER) has instituted a project to identify emerging public health
problems, and to determine how well Agency programs are providing
inspection personnel with the training, equipment, supervision,
and other types of resources that they need to do their jobs well.
Taken together, these steps represent significant progress in
addressing the second challenge. These actions will allow the Agency
to respond to an incident of non-compliance based on risk, rather
than to simply respond to all in the same manner.
The third challenge is the need for improved
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. Data that links foodborne illness outbreaks
with specific foods needs to be connected with prevalence data of
specific pathogens in specific foods. To complete the linkage with
public health outcomes, a strong connection with human health surveillance
data is needed. FSIS, together with our partners in public health
are working to this end through FoodNet.
FoodNet is the Foodborne Diseases Active Surveillance Network.
It is a collaborative project of the CDC, FSIS, FDA, and 10 FoodNet
sites located in various parts of the U.S. Through laboratory surveillance
for infections with certain bacteria and parasites more commonly
transmitted by food, and by conducting special studies, FoodNet
goals are to determine more precisely the burden of foodborne diseases,
monitor foodborne diseases trends, and determine the proportion
of foodborne diseases attributable to specific foods.
FoodNet has been successful in the first two goals. In January
2003, FoodNet formed a working group to determine how to identify
the proportion of foodborne diseases attributable to specific foods.
FSIS has 10 people serving as members of this working group. This
project is of particular importance to FSIS, as the agency looks
for indicators of the success of HACCP and as it looks to identify
areas where improvement may be needed.
So far the working group has examined how outbreak cases contribute
to the overall burden of illness, versus sporadic cases, or non-outbreak
associated cases. The group has been successful in moving the sites
forward in improving the gathering of travel histories for those
ill, as foreign travel is a risk factor for some infections and
may not be associated with eating foods
in this country.
A key project or study for FSIS is the development of mathematical
models to arrive at estimates of the attribution of illnesses caused
by various food commodities. The first such model will target the
contribution to foodborne disease from the various serotypes of
Salmonella. The study will use a mathematical model that
combines the results of surveys of the prevalence of the target
pathogens in all of the major classes of commodities. FSIS verification
testing program data are a key data source for this project. In
the model, these data will be linked to this information from food
consumption surveys and from public health surveillance that tracks
the relative prevalence of the target pathogens in human foodborne
disease. Using these data simultaneously will enable estimates of:
- the relative ability of different pathogens to survive from
reservoir to the point of human ingestion,
- the relative abilities of different pathogens to cause human
disease once ingested, and
- estimates of the contribution of the different food commodities
in causing human foodborne disease.
The model, being developed by the University of Minnesota, is
almost complete. The FSIS working group members are working diligently
to get the FSIS data ready to send to the modeler. A final product
is expected in the fall of 2004.
The fourth challenge is improving food
safety beyond our borders. This challenge was not included
in the 2003 vision document; however, it is important to note that
food safety is an issue of global importance. As such, it needs
to be recognized that FSIS' efforts transcend U.S. borders, and
paying special attention to this reality can help guide the agency's
fulfillment of its vision for food safety. With the proliferation
of movement of people, food and agricultural products between countries,
the likelihood of food that is produced in one country being consumed
on the dinner table in another is increasing. The acceleration and
expansion of this process is evidenced and hastened by the multitude
of regional, bilateral and multilateral trade relationships
being pursued and established among countries. With this trend FSIS
has emerged not only as an established leader in effective food
safety standards and regulations for the U.S., but also as the vanguard
entity responsible for enhanced food safety on a global scale.
In particular, the nations of the Americas make up a regional community
ever more closely entwined in the challenge of ensuring food safety
and security for this hemisphere, and beyond. Open and effective
exchange of information and education on food safety risks, and
on how to control those risks, will play a critical role in improving
the food safety and public health of
To address these concerns, FSIS is working to establish a Food
Safety Institute of the Americas (FSIA) to bring together the region's
resources and serve as a focal point for the exchange of food safety
information. The partnership and collaboration among its member
institutions and organizations will significantly contribute to
a reasoned dialogue about food safety and security issues of concern.
Such an organization can also promote the development of science-based
international food safety
standards. The common language of science will serve to enhance
understanding of the policies and procedures within the activities
of the Codex Alimentarius Commission. The development of the FSIA
and the outreach activities of Codex can synergize the improvement
of public health in all communities in the Americas.
"In today's market, we must take a global approach to
food safety. That means working with our trading partners to improve
the safety of foods worldwide."
Under Secretary Dr. Elsa A. Murano
The goal of the FSIA would be to institutionalize and harmonize
food safety education, information, and communication throughout
the region. The FSIA would carry out major outreach activities to
identify, develop, and coordinate educational programs, as well
as to promote the development of international science-based food
The FSIA is an innovative concept for reaching a broad and diverse
audience in the Americas. It can serve to address food safety concerns
in the region by establishing and enhancing important networks among
regulatory officials; researchers; public health officials; meat,
poultry, and egg processors and producers; and animal producers.
SECTION V: Conclusion
The implementation and maintenance of the strategies described
in this 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 FSIS to continue to refine and enhance these
advances based on its current regulatory authority and available
scientific knowledge, it is essential that the agency continue to
modernize its inspection system through risk-based approaches and
further refine its management agenda in order to have the flexibility
to meet ever changing threats to public health.
The U.S. Department of Agriculture (USDA) prohibits discrimination
in all its programs and activities on the basis of race, color,
national origin, sex, religion, age, disability, political beliefs,
sexual orientation, and marital or family status. (Not all prohibited
bases apply to all programs.) Persons with disabilities who require
alternative means for communication of program information (Braille,
large print, audiotape, etc.) should contact USDA's TARGET Center
at (202) 720-2600 (voice and TDD).
To file a complaint of discrimination write USDA, Director, Office
of Civil Rights, Room 326-W, Whitten Building, 14th and Independence
Avenue, SW, Washington, DC 20250-9410 or call (202) 720-5964 (voice
or TDD). USDA is an equal opportunity provider and employer.