Food Safety and Inspection Service
Washington, DC 20250
U.S. Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
DIRECTIONS FOR THE FUTURE
May 1997
Contents
Introduction Research and the Food Safety Research Group Background Risk Assessment and the Research Agenda Criteria Used to Develop Research Agenda Criteria for Identifying Research Needs The Food Safety Research Agenda General Research Questions Salmonella Campylobacter Listeria Enterohemorrhagic Escherichia coli in General and E. coli O157:H7 Specifically The Risk Assessment Framework FoodNet Update Future Directions Appendix 1: FSIS Food Safety Research Working Group Appendix 2: Fault-Tree Analysis
The U.S. Department of Agriculture has embarked on a series of dramatic
changes to improve food safety and reduce the incidence of foodborne illness
associated with the consumption of meat, poultry, and egg products.
First, the Food Safety and Inspection Service (FSIS), the USDA Agency charged
with ensuring the safety of meat, poultry, and egg products, has made
significant changes in the regulatory structure of its food safety programs by
placing a new emphasis on controlling microbial pathogens. On July 25, 1996,
FSIS issued final regulations on Pathogen Reduction and Hazard Analysis and
Critical Control Point (HACCP) systems (1). The
new regulations require all slaughter and processing establishments to adopt a
system of process control--known as HACCP--to prevent food safety hazards.
To verify that HACCP systems are effective in reducing contamination with
harmful bacteria, FSIS has set pathogen reduction performance standards for
Salmonella that slaughter plants and plants that produce raw, ground meat and
poultry have to meet. In addition, slaughter plants are required to conduct
microbial testing for generic E. coli to verify that their
process control systems are working as intended to prevent fecal contamination,
the primary avenue of contamination for harmful bacteria.
Second, FSIS is implementing a reorganization to better prepare the Agency to
operate in a HACCP environment that will emphasize the prevention of foodborne
illness. One objective of the reorganization is to strengthen the Agency's focus
on public health by creating an Office of Public Health and Science (OPHS).
Within that office, FSIS has established a Division of Epidemiology and Risk
Assessment and a Scientific Research Oversight staff. OPHS will generate and use
the best available science to estimate risks associated with meat, poultry and egg
products and to identify potential interventions consistent with the public health
risks. These risk evaluations will guide FSIS's policy and regulatory decision
making.
Research is extremely important to the success of the Agency's new food safety
initiatives. To effectively address the safety of meat, poultry and egg products,
FSIS needs to know more about the hazards in these products and their relation to
adverse human health outcomes. Because the Agency's food safety strategy has
broadened to cover the entire farm-to-table continuum, its research agenda also
must broaden to address information needs at all points along the farm-to-table
chain. To a large extent, the FSIS research agenda is guided by public health
concerns, the new HACCP Pathogen Reduction regulations and the need to conduct
risk assessments to achieve food safety objectives. It is critical that FSIS
identify and establish the linkages between pathogens present on or in food
animals and consequent human disease and to use this information to identify
effective interventions consistent with the public health risk and to reduce
foodborne illness.
The Food Safety Research Working Group was formed at the request of Michael Taylor,
then Acting Under Secretary for Food Safety, to establish a research agenda that
supports the fundamental changes FSIS is making to food safety regulation. The
ultimate goal of the research agenda is to reduce the incidence of adverse human
health effects associated with the consumption of meat, poultry and egg products.
Using human health effects as the basis for determining FSIS research needs is
consistent with the formal risk assessment process, which provides a framework to
identify data gaps and research needs along the farm-to-table continuum. The Food
Safety Research Working Group was asked to use this concept in their deliberations,
with the following objectives:
(1) to determine research needs for public health goals, (2) to determine what
research is needed to support the Pathogen Reduction and HACCP regulation in
preventing foodborne illness from meat and poultry, and (3) to shift the research
orientation from a technology-based approach to a risk-based approach.
The working group is composed of scientists representing a broad base of expertise,
including individuals with experience in research and knowledge of food safety and
public health issues. The following Federal agencies are represented:
Agricultural Research Service (ARS); Animal and Plant Health Inspection Service
(APHIS); Cooperative State Research, Education & Extension Service (CSREES);
Economic Research Service (ERS); FSIS; Office of the Secretary; Office of Risk
Assessment and Cost Benefit Analysis (ORACBA); Centers for Disease Control and
Prevention (CDC); Food and Drug Administration (FDA); National Institutes of
Health (NIH); and the Department of Defense (DOD). Appendix 1 lists the
participants.
Prior to its first meeting in June 1996, the Food Safety Research Working Group
was given the following background material:
1) FSIS Strategic Plan (2);
2) proposedHACCP/Pathogen Reduction regulation (3);
3) Pathogen Reduction Task Force Subcommittee Report (4);
and 4) FSIS Food Safety Research: Current Activities and Future
Needs (5). The group met again in the fall of 1996 and
communicated extensively by e-mail, fax and regular mailings during that time.
Because FSIS is not a research Agency, it must rely on others, particularly the
research agencies within USDA, to realize its research objectives and provide the
scientific data needed to make regulatory decisions. For this reason, the
longstanding collaboration between FSIS and ARS has increased in importance since
1995, when Congress asked that FSIS discontinue its research in diagnostic methods
development. ARS has been, and is, developing the necessary tools for FSIS to use
in its field laboratories and studies bacterial physiology, ecology, pathogenesis,
growth dynamics of pathogens and methods of predictive microbiology in various
food matrices. The 1996 Progress Report on Food Safety Research conducted by ARS
lists 35 research projects currently being conducted by ARS at the request of
FSIS (6).
FSIS in its own right, and through collaborative projects, has been and is conducting food pathogen surveys and studies to generate information needed to form food safety policies:
Risk Assessment and the Research Agenda
Risk assessment is an integral feature in determining the public health hazards
associated with pathogens and will be prominent in the development and design of
the FSIS research agenda. The Food Safety Research Working Group discussed the
multiple reasons for this approach. In 1994, the U.S. Council for Agricultural
Science and Technology (CAST) created a task force to determine what was currently
known in the scientific community about the risks and consequences of foodborne
pathogens and disease. A major recommendation that came from the CAST task force
was that future food safety policy be based on quantitative microbial risk
assessment (7).
This confirmed and extended earlier recommendations from the National Academy of
Sciences in two studies conducted for FSIS (8),(9).
While the value of risk assessment is without question, the science of risk
assessment, particularly for microbial pathogens, is in a developmental stage.
The fact that the numbers of bacteria in food are not constant is a key challenge
to the application of risk assessment techniques to microbial food safety issues.
Recent advances in predictive microbiology and computer modelling, however, have
begun to allow the first quantitative microbial risk assessments.
The Division of Epidemiology and Risk Assessment, within OPHS, will ensure that
the risk assessment paradigm is incorporated into the spectrum of work throughout
the office. In addition to the actual estimates of risk, the assessment process
provides a systematic approach to organizing the available data and identifying
the need for additional data. Appendix 2 describes the first FSIS risk assessment
project and shows how the Fault Tree Analysis for E. coli O157:H7 in ground beef
served to organize data from outbreak investigations and studies and to highlight
missing data points needed to make decisions at each "node" or branching of the
tree. This illustrates how the risk assessment perspective can be used to
estimate risk to human health potentially encountered along the farm-to-table
continuum and to target research that should have the greatest value in terms
of public health impact.
FSIS will also use risk assessment to evaluate cost-effective risk mitigation
strategies. In this area, risk assessment will help rank alternative strategies
to make economically sound policy decisions and allocate resources optimally.
These processes will become an integral part of FSIS rule making activities, as
required by Congress and the Department. Further, FSIS has stated in the final
rule on Pathogen Reduction and HACCP (10) that
the Agency will work closely with other
Federal agencies to improve the scientific basis for establishing food safety
standards for microbial pathogens. An interagency task force will determine the
research needed for developing a workable approach to quantitative microbial risk
assessment. It is conceivable that members of the Food Safety Research Working
Group will be part of this task force.
Internationally, risk assessment has become the means of ensuring that
countries establish food safety requirements that are scientifically sound and a
means for determining equivalent levels of food safety between countries in
international trade. These requirements are spelled out in the Sanitary and
Phytosanitary provisions of the GATT Agreement (11).
Scientists within FSIS, ARS, and ERS are working to develop risk assessment
models based on predictive microbiology and data available through the various
surveillance and monitoring activities described above. In addition to the fault
tree analysis for E. coli O157:H7 in hamburger, they have developed a "Flow" Tree
Analysis for this same pathogen and food using innovative programming,
incorporating the dynamics of microbial growth and death with the known levels of
pathogen in epidemiologically implicated hamburgers. The Dynamic Flow Tree
Process is described in an article authored by FSIS and published by the Office
of Risk Assessment and Cost Benefit Analysis (ORACBA) (12).
FSIS has also initiated a quantitative risk assessment for shell eggs and egg
products. This project was started in September 1996 and includes scientists
from FSIS, ERS, ARS, APHIS, FDA, CDC, and academia. The project objectives
are (1) to establish the unmitigated risk of salmonellosis associated with the
consumption of contaminated shell eggs and egg products, (2) to address risk along
the farm-to-table continuum, (3) to evaluate various risk mitigation strategies
in terms of effective risk reduction, and (4) to identify data needs and prioritize
data collection efforts. A public process will include opportunity for industry
and consumer input. A project report, including risk-cost-effectiveness/
cost-benefit studies on alternative mitigation strategies, is expected by the end
of 1997.
Criteria Used to Develop the Research Agenda
After reviewing, evaluating and generally discussing the background documents
(see introduction), the Food Safety Research Working Group members used their
considerable expertise to reach a consensus on the major research questions
that needed to be answered. To encourage consideration of all possible issues,
the working group was asked not to be limited by resource constraints in
identifying the research needs. The working group developed criteria for
identifying information needs on adverse health events.
1. Incidence of Adverse Health Outcome
2. Causes of Adverse Health Outcome
a. Chemical
b. Physical
c. Biological
3. Linkage (etiological/vehicle linked to food)
4. Outcomes
a. Sequela
b. Deaths
c. Distribution (demographics/populations)
d. Costs
* Medical
* Productivity Losses
e. Public Sensitivity/Perceptions
Research Agenda
1. What is the actual incidence of foodborne illness in the United States?
What is the incidence by specific pathogen and by specific food product?
2. What is the relationship between the numbers of bacteria on raw product
and foodborne illness, and is the number different for different subpopulations,
e.g., by age, socioeconomic status, immune status, race, etc.? What is
the relationship of changes in performance standards for pathogen reduction
(Salmonella or future performance standards) to human health downstream?
3. What are the risks, i.e., probability of foodborne illness, along
the food chain? How does the determination of risk translate into
the identification of critical control points along the farm-to-table
continuum?
4. Is there adequate information on the sensitivity of subpopulations
exposed to chemical, physical, and microbiological hazards in foods?
Are different intervention strategies more effective for reducing
risk of foodborne illness for different subpopulations?
5. Can critical limits around a control point within a hazard analysis
critical control point (HACCP) system be directly linked to a public
health impact?
6. How are pathogens introduced into the food chain? Studies show that
transportation and/or stress cause an increased shedding of pathogens
in animals; does this increase the number of pathogens on raw product
or the risk of foodborne illness? Are CCPs known in animal production
and, if so, is existing technology available to monitor the limits
around each point?
7. Is it possible to predict emerging foodborne pathogens? For example,
can conditions be identified which increase the likelihood of a pathogen,
or a category of pathogens emerging or re-emerging at any point along
the farm-to-table continuum?
8. Are there effective models for risk communication in relation to
foodborne illness?
9. What are the costs and benefits for risk reduction, and what will
consumers pay for food safety?
10. Are there vaccines or other production level interventions which
would eliminate or reduce pathogens in raw products and/or prevent
foodborne illness?
Research Agenda
Salmonella species cause diarrhea and systemic infections, which can be fatal in
particularly susceptible persons, such as the immuno-compromised, the very young,
and the elderly. An estimated 800,000-4,000,000 infections occur each year in the
United States, most of them as individual cases apparently unrelated to outbreaks.
Animals used for food production are common carriers of salmonellae, which may
subsequently contaminate foods such as meat, dairy products, and eggs. Foods
often implicated in outbreaks include poultry and poultry products, meat and meat
products, dairy products, egg products, seafood and fresh produce. Between
128,000-640,000 of these infections are associated with Salmonella enteritidis
(SE) in eggs. Over the past decade, more than 500 outbreaks have been attributed
to SE with more than 70 deaths. In 1994, an upper limit estimate of 224,000
people became ill from consuming contaminated ice cream in one outbreak alone.
S1. What is the incidence of salmonellosis that can be attributed to cross-contamination,
particularly during food preparation in the kitchen?
S2. What are the sequelae of acute salmonellosis in humans? How common are they, and
which subpopulations are most affected?
S3. How does Salmonella colonize both animals and humans? What are the specific
colonization factors and their role in pathogenesis?
S4. What is the value of Salmonella serotyping? Can we determine seasonality of occurrence
and geographic distribution in animals and/or humans? Is it needed, or is it enough
to evaluate interventions and to identify emerging pathogens and/or antibiotic resistance?
Are alternative methods available to subtype more cost effective, and can they be
correlated with serotype?
S5. Do interventions that control the occurrence of Salmonella in the food chain also control
the occurrence of other foodborne pathogens and non-pathogenic microorganisms? Do
interventions that have an impact on human salmonellosis also control illness caused by
other microorganisms?
S6. What is known about the microbial ecology of Salmonella? What are the environmental
reservoirs for Salmonella along the farm-to-table continuum? What are the survival and
growth characteristics before and after cooking?
Research Agenda
III. Campylobacter
Campylobacter is the most frequently identified cause of acute infectious diarrhea
internationally and is the most commonly isolated bacterial intestinal pathogen
in the United States. It has been estimated that between 170,000-2,100,000 cases
of campylobacteriosis occur annually with an associated 120-360 deaths.
Campylobacter jejuni and Campylobacter coli (two closely related species) are
commonly foodborne, and are the infectious agents most frequently described in
association with Guillain-Barré Syndrome, perhaps as frequently as 1 in a 1000
cases. Several prospective studies have implicated raw or undercooked chicken as
major sources of C. jejuni/coli infections. Unpasteurized milk and untreated
water have also caused outbreaks of disease.
C1. What is the incidence of campylobacteriosis that can be attributed to cross-contamination,
particularly during food preparation in the kitchen?
C2. What are the sequelae of acute campylobacteriosis in humans? How common are they,
and which subpopulations are most affected? Which strains (serotypes) of Campylobacter
are associated with Guillain-Barré Syndrome?
C3. How does Campylobacter colonize both animals and humans? What are the specific
virulence factors, including colonization?
C4. What interventions in the food chain (particularly farm practices) will decrease human
illness or infections by Campylobacter? How can we measure the impact of interventions?
C5. What is the best method of subtyping Campylobacter for epidemiologic purposes?
C6. How can Campylobacter be detected in foods and in humans economically?
Research Agenda
IV. Listeria
Listeria monocytogenes is ubiquitous and is recognized as an important foodborne
pathogen that can replicate at refrigeration temperatures. Listeriosis is a severe
disease (e.g., causing conditions such as meningitis, spontaneous abortion, and
septicemia) with a high fatality rate (20-30% of cases). Host susceptibility
plays a major role particularly with infants, the elderly, pregnant women, and
immuno-compromised individuals. Epidemiological data implicate meat, poultry,
and dairy products among the food vehicles of listeriosis. Reports covering
1971-1994 indicate the prevalence of L. monocytogenes in meats to be highly
variable with about 16 percent of products being positive. Data accumulated
during the past ten years indicate that the highest risk foods are often
ready-to-eat and stored at refrigeration temperatures for days to weeks.
Public health agencies and regulatory agencies have established a zero tolerance
for L. monocytogenes in cooked, ready-to-eat food.
L1. How common are gastroenteritis, flu-like, or other "mild" symptoms due to Listeria
monocytogenes infection? What are the sequelae of acute listeriosis in humans? How
common are they and which subpopulations are most affected?
L2. What is the infectious dose and the dose-response relationship of L. monocytogenes for
humans and animals? Does a threshold exist below which illness does not occur? Is a
zero tolerance standard supportable by scientific evidence?
L3. Is the presence of L. monocytogenes a concern in raw food products?
L4. Where is L. monocytogenes in the production/processing plant, and can it be eliminated?
L5. Are methods available to isolate and identify L. monocytogenes from foods and human
fecal specimens?
Research Agenda
V. Enterohemorrhagic Escherichia coli in General and E. coli O157:H7
Specifically
Several strains of the bacterium E. coli cause a variety of diseases in humans and
animals. Some strains produce Shiga toxins and are associated with a particularly
severe form of human disease in many countries around the world; they are called
enterohemorrhagic E. coli (EHEC). E. coli O157:H7 and a few other serotypes of
EHEC (e.g. O111:NM and O26:H11) cause hemorrhagic colitis, which begins with
watery diarrhea and severe abdominal pain and rapidly progresses to passage of
bloody stools, and has been associated with Hemolytic Uremic Syndrome (HUS).
HUS is a life-threatening complication characterized by acute kidney failure,
and is particularly serious in young children. E. coli O157:H7 has its primary
reservoir in cattle (also in deer and sheep), but the dynamics of E. coli 0157:H7
and other EHEC in food-producing animals are not well understood. An estimated
25,000 cases of foodborne illness can be attributed to E. coli O157:H7 each year
with as many as 100 deaths resulting. Recent E. coli O157:H7 outbreaks have been
associated with ground beef, venison, raw milk, lettuce and minimally-processed
and fresh fruit juices. The most recent outbreak in the fall of 1996 in three
western states and British Columbia which was associated with unpasteurized apple
juice, sickened 66 people and caused the death of one child. Much less is known
about other EHEC, some of which have caused major outbreaks in Australia and Europe.
E1. What is the incidence of EHEC and E. coli O157:H7 disease/infection in humans and
animals in the United States? What is the relative incidence among different
subpopulations?
E2. What are the virulence factors associated with EHEC? Are all Shiga toxin-producing E.
coli (STEC) pathogenic for humans, i.e., are all STEC also considered EHEC? Which
virulence factors are associated with bloody diarrhea, hemolytic uremic syndrome, or
other sequelae?
E3. How do EHEC colonize both animals and humans?
E4. What is the infectious dose and the dose-response relationship of EHEC and E. coli
O157:H7 for humans and animals? Does a threshold exist below which illness does not
occur? Is a zero tolerance standard supportable by scientific evidence? Can dose
response data calculated for Shigella sp. or S. dysenteriae type 1, be used for EHEC and
E. coli O157:H7?
E5. What is known about the microbial ecology of EHEC and E. coli O157:H7? What are the
environmental reservoirs for EHEC and E. coli O157:H7 along the farm-to-table
continuum? What are survival and growth characteristics before and after cooking?
E6. Should we be screening E. coli from human disease, and/or from food, for toxin
production, or for the presence of stx, eae, hyl, EHEC plasmid, adhesins, etc.? Should we
be screening human fecal specimens and/or foods for the presence of Shiga toxins?
The Food Safety Research Working Group also evaluated the research agenda as it
should or could fit with the traditional risk assessment framework. Subheadings
within each classification category describe specific research issues in terms of
both risk assessment and HACCP.
|
Classification |
General | Salmonella | Campylobacter | Listeria | EHEC |
| Hazard ID:
Incidence (human, animal, food) Pathogenesis Diagnostics Food Vehicles |
1, 6, 10 2, 7 2 |
S1, S6 S2, S3, S6 S4 S4 |
C1 C2, C3 C5 C5 |
L1 L5 L3, L5 |
E1, E5 E2,E3,E6 E6 E6 |
| Dose-Response Assessment
General Population Sub-Populations |
2, 4 2, 4 |
S2 S2 |
C2 C2 |
L1, L2 L1, L2 |
E4 E4 |
| Exposure Assessment
Points of Introduction Growth and Decline Cross-Contamination |
6, 7 2, 6 |
S6 S1 |
C1 |
L4 L2 L4 |
E5 |
| Risk Characterization | 2, 3, 5 | -- | C4 | -- | -- |
| Risk Management
Interventions CCP Identification Sub-Populations |
4, 10 2, 3 2, 4 |
S5 |
-- |
L4 L4 |
--
|
| Cost-Benefit Analysis | 9 | -- | -- | -- | -- |
| Risk Communication/Education/Consumer Behavior | 8 | -- | -- | -- | -- |
First year (1996) data from the joint USDA, FDA, CDC FoodNet project, which was
summarized and reported to Congress in February 1997, indicate that Campylobacter
is the most frequent cause of foodborne disease in the United States (13).
This is something that public health officials had suspected for some time but could not
demonstrate, because current surveillance (other than FoodNet) data are based mainly
on the reports of outbreaks of disease, while Campylobacter primarily causes
sporadic disease. FSIS is particularly concerned because several small prospective
studies have linked the preparation or consumption of raw or undercooked poultry
with Campylobacter infections. That concern was heightened by a 1996 conference
sponsored by NIH, which linked acute Campylobacter infections to severe outcomes
such as Guillain-Barré Syndrome. Consequently, FSIS convened a meeting with CDC,
FDA, and ARS scientists to discuss research needs, particularly methodology to
improve the costly and time-consuming methods now required to sample, isolate,
and identify this pathogen. This will be the first step to develop methods and
procedures that FSIS can then apply in field studies necessary to generate
information for risk estimates and intervention strategies.
The Research Agenda outlined above will be used to develop an operational plan
for meeting research needs. However, the Food Safety Research Working Group also
has a broader impact on food safety activities:
| Dr. Kaye Wachsmuth (CHAIR) Acting Deputy Administrator Office of Public Health & Science Food Safety & Inspection Service, USDA Jamie L. Whitten Bldg. 12th & Jefferson Drive, SW, Room 341E Washington, DC 20250 (202) 720-2644 FAX (202) 690-2980 |
Dr. J. Glenn Morris, Jr. (CO-CHAIR) Office of Public Health & Science Food Safety & Inspection Service, USDA Jamie L. Whitten Bldg. 12th & Jefferson Drive, SW, Room 341E Washington, DC 20250 (202) 205-0293 FAX (202) 690-2980 |
| Dr. Nell Ahl Office of Risk Assessment and Cost Benefit Analysis, USDA South Agriculture 5248 Stop 3811 14th & Independence Ave, SW Washington, DC 20250 (202) 720-8022 FAX (202) 720-1815 |
Dr. Robert L. Buchanan Microbiologist USDA/ARS/ERRC Plant Science & Food Safety Research Unit 600 E. Mermaid Lane Wynmoor, PA 19038 (215) 233-6636 FAX (215) 233-6406 |
| Dr. Bonnie Buntain Director, Animal Production Food Safety Staff Food Safety & Inspection Service, USDA Room 0002 South Building 14th & Independence Ave., SW Washington, DC 20250 (202) 690-2683 FAX (202) 720-8213 |
Dr. Mitchell Cohen Director, Division of Bacterial & Mycotic Diseases Centers for Disease Control & Prevention 1600 Clifton Road, Mail Stop C-09 Atlanta, GA 30444 (404) 639-1603 FAX (404) 639-2780 |
| Dr. Franklin L. Flora Cooperative State Research, Education & Extension Service, USDA 8th Floor, Aerospace Bldg., Mail Stop 2220 Washington, DC 20250-2220 (202) 401-1954 FAX (202) 401-4888 |
Dr. Betsey Kuhn Director, Food & Consumer Economics Division Economic Research Service, USDA 1301 New York Ave., NW Room 1108 Washington, DC 20005-4788 (202) 219-0409 FAX (202) 219-0869 |
| Dr. John R. LaMontague Director, DMID, NIH Solar Bldg, Room 3A18 6003 Executive Bldg. MSC 7630 Bethesda, MD 20892-7630 (301) 496-1884 FAX (301) 480-4528 |
Dr. Dennis R. Lang Enteric Diseases Branch, NIH Solar Bldg., Room 3A21 6003 Executive Blvd., MSC 7630 Bethesda, MD 20892-7630 (301) 496-7051 FAX (301) 402-1456 |
| Dr. Joseph Madden Strategic Manager for Microbiology Center for Food Safety &Applied Nutrition, FDA 200 C. Street, Room 5836 Washington, DC 20204 (202) 205-4197 FAX (202) 401-2893 |
Dr. Alison O'Brien Dept. of Microbiology Uniformed Services University of the Health Sciences 4301 Jones Bridge Road Bethesda, MD 20814-4799 (301) 295-3400 FAX (301) 295-3773 |
| Dr. Morris Potter Centers for Disease Control & Prevention 1600 Clifton Road, Mail Stop A-38 Atlanta, GA 30333 (404) 639-1603 FAX (404) 639-2212 |
Dr. Jane Robens National Program Leader Food Safety & Health, ARS, USDA Bldg. 5, Room 210 10300 Baltimore Ave. Beltsville, MD 20705 (301) 504-5381 FAX (301) 504 5467 |
| Dr. Tanya Roberts Agricultural Economist Economic Research Service, USDA 1301 New York Ave., NW. Room 1108 Washington, DC 20005-4788 (202) 219-0857 FAX (202) 219-1252 |
Dr. Al Strating Acting Associate Administrator Animal & Plant Health Inspection Service, USDA Jamie L. Whitten Bldg., Stop 3401 12th & Jefferson Drive, SW, Room 321E Washington, DC 20250 (202) 720-3861 FAX (202) 720-3054 |
| Dr. Sephen F. Sundloff Director, Center for Veterinary Medicine Food and Drug Administration 7500 Standish Place, HFV-1 Rockville, MD 20855 (301) 594-1740 FAX (301) 592-1830 |
Dr. Catherine W. Woteki Acting Under Secretary Research, Education & Economics, USDA Jamie L. Whitten Bldg., Room 217W 12th & Jefferson Drive, SW Washington, DC 20250 (202) 720-8885 FAX (202) 690-2842 |
| Following is a proposed structure for a fault tree model developed by Peg Coleman, of the Food Safety and Inspection Service, and Tanya Roberts, of the Economic Research Service. Data from the various stages of the farm-to-table chain can be incorporated into the model to determine the risk associated with the ground beef. |
QUANTITATIVE EVIDENCE
NODE 3 - What beef products are NODE 7 - How is ground beef cooked?
characterized for O157:H7? 23% serve undercooked
Prevalence data from nationwide random and (Klontz et al., 1995)
targeted surveys:
4/2081 (FSIS steer/heifer baseline, 1994) 3% rare, 16% medium-rare, 17% medium,
0/563 (FSIS ground beef baseline, 1995) 23% M-W, 39% well, 3% don't eat ground beef
3/5291 (FSIS testing program, 1995) (TX consumers, McIntosh et al., 1994)
2/2485 federal plants
1/2740 retailers NODE 10 - Does supermarket grind?
0/37 state plants 94% grind own ground beef
0/29 imports 6% purchase fine grind or packaged
(ERS data, 1990 industry survey)
NODE 4 - Where is ground beef consumed?
52% fast food NODE 14 - What are supermarket sources
33% at home for ground beef?
10% restaurant or institution 16% coarse ground
5% other locations 9% beef for grinding
(ERS data) 5% fine ground
70% boxed beef (trim)
NODE 5 - Is ground beef eaten cooked? (ERS data, 1990 industry survey)
95% eaten cooked, 5% raw, steak tartare
(Klontz et al., 1995). Contamination probability for each ??
1. Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems; Final Rule. 9 CFR Part 304, et al. July 25, 1996.
2. Draft FSIS Strategic Plan, March 31, 1996
3. Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems Proposed Rule, 9 CFR Part 308, et al., February 3. 1995. (Final Rule published July 26, 1996).
4. Subcommittee Report for the Pathogen Reduction Task Force-Identifying Research and Educational Needs, USDA
5. Food Safety Research: Current Activities and Future Needs, FSIS, USDA, March 31, 1995
6. 1996 Progress Report on Food Safety Research Conducted by ARS, USDA, October 15, 1996.
7. Foodborne Pathogens: Risks and Consequences. Council for Agricultural Science and Technology Ames, Iowa. 1994.
8. Meat and Poultry Inspection: The Scientific Basis of the Nation's Program. Report of the Committee on the Scientific Basis of the Nation's Meat and Poultry Inspection Program, Food and Nutrition Board. National Academy Press, Washington, D.C., 1985.
9. Poultry Inspection--The Basis for a Risk-Assessment Approach. Report of the Committee on Public Health Risk Assessment of Poultry Inspection Programs, Food and Nutrition Board. National Academy Press, Washington, D.C., 1987.
10. Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems; Final Rule. 9 CFR Part 304, et al. July 25, 1996. P. 38847.
11. World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures (The SPS Agreement). This agreement constitutes an elaboration of the relevant provisions, in particular Article XX(b), of the 1994 General Agreement on Tariffs and Trade.
12. Coleman, Peg, "FSIS/ERS Microbial Risk Assessment Collaboration: Dynamic Flow Tree Process," ORACBA News, March-April 1997, p. 2.
13. FSIS/CDC/FDA Sentinel Site Study: The Establishment and Implementation of an Active Surveillance System for Bacterial Foodborne Diseases in the United States, FSIS, USDA. Report to Congress. February, 1997.
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