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Office of Public Health Science, FSIS
Food Safety Risk Assessments
Janell Kause, DirectorRisk Assessment Division
Office of Public Health ScienceFood Safety and Inspection Service, USDA
2009 Meat Industry ConferenceTechnical Developments: The New Economic Reality
Chicago, IL, October 27, 2009
Office of Public Health Science, FSIS
• Public health agency in USDA- considers entire food safety system (from production to table)- collaborates with FDA, APHIS, and other food safety agencies
• Ensure meat, poultry and processed egg products are safe, wholesome, and correctly labeled and packaged
• Statutory requirements- Federal Meat Inspection Act, Poultry Products Inspection Act, and the Egg Products Inspection Act
• Scientific tools to guide food safety decisions- data & understanding: epidemiology (risk factors/attribution), food
testing (identification of hazards – chemical, microbial, etc.)- prediction & prevention: risk assessment
Food Safety and Inspection Service
Office of Public Health Science, FSIS
Annual estimates of foodborne disease*• 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths
Emerging concerns• STECs (non-O157), Clostridium difficile, norovirus, specific sub-types of
known pathogens• nanotechnology, GMOs, allergens, antimicrobial resistance
• dioxin, melamine, other chemical contaminants
Cross-cutting issues• safety & freshness associated with locally grown; direct farm-to-market
• globalization: equivalence (WTO/SPS Agreement)
• effectiveness/consistency in labeling: nutrition/food safety
• food safety interventions: nutrition, quality, acceptance; risk trade offs
Public Health Context
* Centers for Disease Control and Prevention (Mead et al., 1999); updated estimates expected CY 2010
Lm
Campylobacter
Salmonella
E. coli O157:H7
Office of Public Health Science, FSIS
• Cornerstone of our food safety
program– safety of meat, poultry, and egg products
– entire food safety system
– partnership with other agencies (FDA, APHIS, EPA, CDC), states, and academia
• Powerful tool to guide the development of food safety policy– current and emerging food safety issues
– transparency and stakeholder involvement to
ensure credibility and scientific accountability
Risk Analysis at USDA/FSIS
FSIS Risk Analysis Standard Operating Procedures: www.fsis.usda.gov/oppde/rdad/frpubs/rasops.pdf
Risk Assessors
Risk Managers
Risk Communicators
Inform risk management options
Effective decisions to improve food safety
Office of Public Health Science, FSIS
What is Risk Assessment?
• Scientific process for estimating the probability of exposure to a hazard and the resulting public health impact (risk); consists of the following components:
• Predicts public health benefits of changes in policies, practices, and operations (and includes the certainty of these predictions).
• It is used to facilitate the application of science to policy (the “bridge between data and decisions”).
1. hazard identification2. hazard characterization 3. exposure assessment 4. risk characterization
Office of Public Health Science, FSIS
• Regulatory Requirements (Public Law 103-354) – The Federal Crop Insurance Reform and Department of
Agriculture Reorganization Act of 1994 requires that any regulation published by USDA concerning human health, human safety or the environment and having an annual economic impact of at least $100 million in 1994 dollars contain a risk assessment and cost-benefit analysis.
• World Trade/SPS Agreements (equivalency)
• Presidential Executive Order 12866, significant regulatory actions– http://www.whitehouse.gov/omb/inforeg/eo12866.pdf
Regulatory Requirements for Risk Assessment
Office of Public Health Science, FSIS
ExplicitObjective
QuantitativeMore Data
More ResourcesBroad Scope
ImplicitSubjectiveQualitativeLess Data
Fewer ResourcesNarrow Scope
Qualitative Quantitative
Types of Risk Assessments
The “best” risk assessment is the one that most directly informs the risk management issue.
ScreeningRisk profile
Categorical Scoring
Systems modelsStochastic models
Uncertainty Analysis
High/Medium/Low
Office of Public Health Science, FSIS
8
Codex process for microbial risk assessment (RA)
• Hazard Identification• In-depth literature review
• Hazard Characterization• Dose-response
• Exposure Assessment• Likely intake of pathogen
• Risk Characterization• Consequences, given the above
National Resource Councilprocess for chemical RA
• Hazard Identification
• Dose-Response
• Exposure Assessment
• Risk Characterization
Risk Assessment Process
Office of Public Health Science, FSIS
Overview: Risk Assessment Applications
Examineinterventions
Examineinterventions
Developperformance
standards
Developperformance
standards
Food Safety Risk Assessment: Bridge Data and DecisionsFoodborne
illnesses data &Laboratory
studies
Foodborne illnesses data &
Laboratorystudies
Scien
tific
D ata
Risk
Ass
essm
ent Hazard
IdentificationHazard
IdentificationHazard
Characterization(Dose-Response)
HazardCharacterization(Dose-Response)
Risk Characterization
Slaughter &Processing
Slaughter &Processing
FarmProduction
FarmProduction RetailRetail HomeHome
Exposure Assessment
PredictLikelihood of Illness
Identifycritical control
points
Identifycritical control
points
Environmentalconditions (time,
temp., pH, interventions)
Environmentalconditions (time,
temp., pH, interventions)
Consumerfood handling behavior & diet
Consumerfood handling behavior & diet
Amount of hazard (PBPK modeling;
predictive microbiology)
Amount of hazard (PBPK modeling;
predictive microbiology)
Testing data (chemicals and
microbes)
Testing data (chemicals and
microbes)
Evaluatechanges in practices &
policies
Evaluatechanges in practices &
policies
Determine equivalenceDetermine
equivalenceAppl
icatio
ns Prioritize food safetyresearch
Prioritize food safety
researchAllocate
resourcesAllocate
resources
Quantitative risk assessment integrates a wide variety of science and data to provide a comprehensive understanding of the food safety system.
Office of Public Health Science, FSIS
Current• Establish food safety policies (policy development)• Allocate inspection resources to verify industry controls (assurance)• Measure federal performance in achieving public health goals (evaluation)
Future• Standardize and harmonize risk assessment methodology• Establish measurable performance objectives for industry based on national
public health goals (risk management metrics)• Address both chemical and microbial hazards simultaneously in assessing risk
from foods• Apply probabilistic approach to address chemical food safety risks• Integrate multiple environmental exposure routes of a hazard into food safety
system in determining food safety risk
Risk Assessment Applications at USDA/FSIS
Office of Public Health Science, FSIS
• Systematically address food safety issues
• Formal and transparent conceptual framework that integrates data and information to guide decisions
– logical– science based – transparent– holistic
• Evaluate public health benefits associated with policy options (“what if” scenarios)
• Focus finite resources on the greatest risk (foods, hazards, process, and/or practices)
• Several applications for public health professionals, food safety managers, and other stakeholders
Why is risk assessment used to guide decisions?
Office of Public Health Science, FSIS
Questions Involving the Use of Risk Assessment
How do you determine if there is an emerging food safety issue?
How are risk assessments developed to guide food safety policies?
Office of Public Health Science, FSIS
Evaluating Emerging Food Safety Issues & Developing Risk Management Strategies
1. Evaluate Food Safety Problem 2. Public Health Goals
- Healthy People 2020- Risk management objectives
4. Identify Viable Policy Options
- cost-effectiveness- legal constraints- technically feasible
- Identify emerging issues/ improve understanding of existing issues
- Develop Risk Profile
6. Select Food Safety Policy
- Balance public health benefits (risk reduction) with societal costs
5. Regulatory Impact Analysis
- Conduct a risk assessment- Conduct a cost-benefit analysis
7. Implement Food Safety Policy
- regulation - guidance
- training - outreach
- allocate resources
8. Evaluate Effectiveness of Food Safety Policy
- inspection - FSAs- verification sampling- attribution data (trend analysis)
3. Formulate Various Policy Options
- Agency-wide input- External (Stakeholder) Input
Office of Public Health Science, FSIS
Which ready-to-eat foods pose the greatest risk of listeriosis?
• FDA-FSIS Quantitative Assessment of the Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods (2001, updated 2003)
Which industry practices effectively control Lm?• FSIS Risk Assessment for Listeria monocytogenes in Deli Meat (2003)
How can FSIS target its inspection resources to ensure industry controls Lm?
• FSIS Risk Based Verification Sampling for Listeria monocytogenes in Ready-to-Eat Meat and Poultry Products (2005)
Where should FSIS focus its efforts to further to reduce listeriosis?
• FSIS Comparative Lm Risk Assessment: Pre-packaged vs. Retail-sliced Deli Meat (2009)
Managing the Risk of Listeriosis: Use of Various Types of QMRAs
Office of Public Health Science, FSIS
• FDA/FSIS Listeria risk
assessment identified deli
meats as posing the greatest
risk of listeriosis
• Action: Lm Food Safety
Action Plan
• Caveat: Predicted deli meat
posed greatest risk prior to
foodborne outbreaks
beginning in Fall 2002
-5.00
-4.00
-3.00
-2.00
-1.00
0.00
1.00
2.00
3.00
4.00
Tota
l Cas
es L
iste
riosi
s pe
r Ann
um (l
og s
cale
)
DM
PM
HFD
FNR
SU
C P
CRUM
SSF
FRV
DFS
FSC
SS
CS
RC
DS RS
PF IC PC
CD
HC
Deli meats Frankfurters (heated)
23 Categories of Ready-to-Eat Foods
Which foods pose the greatest risk of listeriosis?
Office of Public Health Science, FSIS
• FSIS Listeria risk assessment
identified post-lethality
interventions and use of
antimicrobials were
substantially more effective
than sanitation measures
• Action: Interim Final Rule for
Lm (2003)
• Caveat: Changed FSIS risk
management strategy to focus
beyond testing/sanitizing
Source: http://www.fsis.usda.gov/PDF/Lm_Deli_Risk_Assess_Final_2003.pdf
Which industry practices effectively control Lm?
Office of Public Health Science, FSIS
• FSIS’ risk-based Lm sampling
allocated FSIS verification sampling
resources among establishments
predicted to pose the greatest risk
each month (10,000 samples/year)
• Result: industry adopted more
effective Lm control measures
• Caveat: first risk-based food safety
inspection program in U.S. using
QMRAs
AlternativeSampling PP GI PP&GI
Frac
tion
of R
TE D
eli
Mea
t Pro
duct
ion
0.0
0.2
0.4
0.6
0.8Pre regulationCurrent
Industry adoption of Lm controls
How can FSIS effectively allocate its inspection resources to ensure Lm controls?
Source: http://www.fsis.usda.gov/PDF/RBVS_Risk_Assess_Jun07.pdf
Office of Public Health Science, FSIS
Why a plateau in listeriosis?
FSIS Regulatory Testing for Lm in RTE Products by Calendar Year 1990-2008
(All Years All Projects)
4.60%
4.03%
3.61%3.44%
2.90% 3.02% 2.91%
2.25%2.54%
1.91%
1.45% 1.32%1.03%
0.76%0.55% 0.64% 0.61%
0.43% 0.42%
0.0%
0.5%
1.0%
1.5%
2.0%
2.5%
3.0%
3.5%
4.0%
4.5%
5.0%
1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
Calendar Year
Perc
ent P
ositi
ve
Incidence of Foodborne Illnesses 1996-2008: Listeria
Preliminary FoodNet data on the incidence of infection with pathogenstransmitted commonly through food … 10 States, 2008
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
Calendar Year
Inci
denc
e pe
r 10
0,00
0
National Health Objective:0.24 Cases per 100,000
Percent Positive Listeria in Product1990-2008
Incidence of Foodborne Listeriosis1996-2008
Reduction in Lm Contamination and Listeriosis in the U.S.
Office of Public Health Science, FSIS
• FSIS comparative Lm risk assessment evaluated the risk of listeriosis from prepackaged vs. retail-sliced deli meat
• Finding: approximately 83% of listeriosis cases attributed to deli meat were associated with those sliced at retail (growth inhibitors significantly reduce risk overall)
• Action: FSIS and FDA focus on retail Lm contamination --developing a new risk assessment to evaluate retail cross-contamination and Lm controls
Source: http://www.fsis.usda.gov/PDF/Comparative_RA_Lm_Report.pdf
2009 FSIS Comparative Lm Risk Assessment: Pre-packaged vs. Retail-sliced Deli Meat
Where should we focus our efforts to further reduce listeriosis?
Office of Public Health Science, FSIS
• Tiered approach to understanding and controlling Lm– Identify which food vehicle posed the greatest risk (Lm Action Plan)– Identify which processing intervention would best control Lm (FSIS Listeria Rule)– Identify where to focus inspection efforts among processors (FSIS risk-based
sampling)– Identify where further reductions in listeriosis can be realized (e.g.,
retail/sanitation) – Understand how cross-contamination occurs to effectively control Lm at retail
• Risk assessment findings guided Agency and industry efforts to successfully reduce Lm contamination in meat and poultry products
• RA: identified and provided basis for implementing better Lm controls
Using RA to Successfully Mitigate Listeriosis in the U.S.
Office of Public Health Science, FSIS
• Must have well defined risk management questions
• RAs are not a “one size fits all”
• Complexity of the RA depends on the purpose for developing the risk assessment
• Risk assessors and risk managers are independent, but interdependent
• Risk profiles are essential for characterizing the current public health risk for emerging hazards (tiered approach to risk assessment)
Lessons Learned
Office of Public Health Science, FSIS
• Involve stakeholders early in the process• RA models can be modular and built more
quickly using prior risk assessment models • Integrating economics and risk assessment
into a single model saves time in decision-making
• Use risk assessments as a predictive tools -conduct scenario analyses
• Characterization of certainty of risk estimates is important for decision makers
• Rigorous peer review is essential
Lessons Learned
Office of Public Health Science, FSIS
• Broader food safety perspective and use of risk assessments
• Food safety risks will be “food-based” (multiple hazards) rather than traditional product-hazard based
• Risk management metrics: predict which performance objectives will meet established public health goal
• Increasing interagency collaboration & consideration of cross-cutting issues
• Evaluation of risk-risk trade offs
• Greater focus on emerging issues and prevention
Future Direction
Office of Public Health Science, FSIS
FSIS Risk Assessment Website: www.fsis.usda.gov/Science/Risk_Assessments/index.asp
Janell Kause, DirectorRisk Assessment Division
Office of Public Health ScienceFood Safety and Inspection Service
U.S. Department of Agriculture
E-mail: Janell.kause@fsis.usda.gov
Contact Information