Food Safety Risk Assessments

Office of Public Health
Science, FSIS
Food Safety Risk Assessments
Janell Kause, Director

Risk Assessment Division
Office of Public Health Science
Food Safety and Inspection Service, USDA
2009 Meat Industry Conference

Technical Developments: The New Economic Reality
Chicago, IL, October 27, 2009
Food Safety and Inspection Service

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
Public Health Context

Science, FSIS
Annual estimates of foodborne disease*

• 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths Campylobacter
Emerging concerns
• STECs (non-O157), Clostridium difficile, norovirus, specific sub-types of Lm
known pathogens
• nanotechnology, GMOs, allergens, antimicrobial resistance
• dioxin, melamine, other chemical contaminants Salmonella
Cross-cutting issues
E. coli O157:H7
• 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
* Centers for Disease Control and Prevention (Mead et al., 1999); updated estimates expected CY 2010
Risk Analysis at USDA/FSIS

Science, FSIS Risk Risk
Assessors Managers
• Cornerstone of our food safety
program Risk
Communicators
– safety of meat, poultry, and egg products
– entire food safety system
– partnership with other agencies (FDA, APHIS, Inform risk
EPA, CDC), states, and academia management options
• Powerful tool to guide the Effective decisions to

improve food safety
development of food safety policy
– current and emerging food safety issues FSIS Risk Analysis Standard
Operating Procedures:
– transparency and stakeholder involvement to www.fsis.usda.gov/oppde/rd
ad/frpubs/rasops.pdf
ensure credibility and scientific accountability
What is Risk Assessment?

Science, FSIS
• Scientific process for estimating the probability of exposure to a

hazard and the resulting public health impact (risk); consists of
the following components:
1. hazard identification
2. hazard characterization
3. exposure assessment
4. risk characterization
• 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”).
Regulatory Requirements for
Risk Assessment
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
Types of Risk Assessments

Science, FSIS
Quantitative
Qualitative
Screening Systems models
Risk profile Stochastic models Explicit
Implicit Categorical Scoring Uncertainty Analysis
Subjective Objective
Qualitative Quantitative
Less Data More Data
Fewer Resources More Resources
Narrow Scope Broad Scope
High/Medium/Low
The “best” risk assessment is the one that most

directly informs the risk management issue.
Risk Assessment Process

Science, FSIS
Codex process for microbial National Resource Council

risk assessment (RA) process for chemical RA
• Hazard Identification • Hazard Identification

• In-depth literature review
• Hazard Characterization • Dose-Response
• Dose-response
• Exposure Assessment • Exposure Assessment
• Likely intake of pathogen
• Risk Characterization • Risk Characterization
• Consequences, given the above
8
Overview: Risk Assessment Applications

Science, FSIS Food Safety Risk Assessment: Bridge Data and Decisions
Scientific Data
Foodborne
Foodborne Amount
Amountofofhazard
hazard Environmental
Environmental
Testing
Testingdata
data Consumer
Consumer
illnesses
illnessesdata
data&& (PBPK
(PBPKmodeling;
modeling; conditions
conditions(time,
(time,
(chemicals
(chemicalsand
and food
foodhandling
handling
Laboratory
Laboratory predictive
predictive temp.,
temp.,pH,
pH,
microbes)
microbes) behavior
behavior&&diet
diet
studies
studies microbiology)
microbiology) interventions)
interventions)
Exposure Assessment
Hazard
Hazard
Hazard
Hazard Farm
Farm Slaughter
Slaughter&&
Characterization
Characterization Retail
Retail Home
Home
Identification
Identification Production
Production Processing
Processing
Risk Assessment
(Dose-Response)
(Dose-Response)
Risk Characterization
Predict
Likelihood of Illness
Applications
Prioritize Evaluate
Evaluate
Prioritize changes
changes inin
food
food safety
safety
research practices
practices &&
research policies
policies
Develop Allocate
Allocate
Develop Identify resources
performance
performance Identify Determine Examine resources
critical
critical control
control Determine Examine
standards
standards equivalence
equivalence interventions
interventions
points
points
Quantitative risk assessment integrates a wide variety of science and data

to provide a comprehensive understanding of the food safety system.
Risk Assessment
Applications at USDA/FSIS
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
Why is risk assessment used to guide decisions?

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
Questions Involving the Use of Risk Assessment

Science, FSIS
How do you determine if there is an

emerging food safety issue?
How are risk assessments developed

to guide food safety policies?
Evaluating Emerging Food Safety Issues &
Developing Risk Management Strategies
Science, FSIS
1. Evaluate Food Safety Problem 2. Public Health Goals 3. Formulate Various Policy Options
- Identify emerging issues/ improve

understanding of existing issues - Healthy People 2020 - Agency-wide input
- Develop Risk Profile - Risk management objectives - External (Stakeholder) Input
6. Select Food Safety Policy 5. Regulatory Impact Analysis

4. Identify Viable Policy Options
- Balance public health benefits - Conduct a risk assessment - cost-effectiveness

(risk reduction) with societal - Conduct a cost-benefit analysis
- legal constraints
costs - technically feasible
7. Implement Food Safety Policy 8. Evaluate Effectiveness of Food

Safety Policy
- regulation - guidance
- inspection - FSAs
- training - outreach - verification sampling
- allocate resources - attribution data (trend analysis)
Managing the Risk of Listeriosis:
Use of Various Types of QMRAs
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)
Which foods pose the greatest risk of listeriosis?

Science, FSIS
• FDA/FSIS Listeria risk

23 Categories of Ready-to-Eat Foods
assessment identified deli
4.00
meats as posing the greatest
Total Cases Listeriosis per Annum (log scale)

3.00
2.00
risk of listeriosis 1.00
0.00
• Action: Lm Food Safety

-1.00
-2.00
Action Plan -3.00
-4.00
-5.00
• Caveat: Predicted deli meat
UM
DM
F
P
RS
HFD
FNR
SUC
CR
FSC
IC
CD
HC
PM
PF
SS
DFS
DS
FR
SSC
SRC
PC
posed greatest risk prior to
foodborne outbreaks Deli meats Frankfurters
(heated)
beginning in Fall 2002
Which industry practices effectively control Lm?

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 Source:
http://www.fsis.usda.gov/PDF/Lm_Deli_Risk
beyond testing/sanitizing _Assess_Final_2003.pdf
How can FSIS effectively allocate its inspection
resources to ensure Lm controls?
Science, FSIS
Industry adoption of
• FSIS’ risk-based Lm sampling Lm controls
0.8
allocated FSIS verification sampling
Fraction of RTE Deli

Pre regulation
Current
Meat Production
resources among establishments 0.6
predicted to pose the greatest risk

0.4
each month (10,000 samples/year)
0.2
• Result: industry adopted more
0.0
effective Lm control measures Sampling PP GI PP&GI
Alternative
• Caveat: first risk-based food safety
Source:
inspection program in U.S. using http://www.fsis.usda.gov/PDF/RBVS
_Risk_Assess_Jun07.pdf
QMRAs
Reduction in Lm Contamination
and Listeriosis in the U.S.
Science, FSIS
Percent Positive Listeria in Product Incidence of Foodborne Listeriosis

1990-2008 1996-2008
FSIS Regulatory Testing for Lm in RTE Products by Calendar Year
1990-2008 Incidence of Foodborne Illnesses
(All Years All Projects) 1996-2008: Listeria
Preliminary FoodNet data on the incidence of infection with pathogenstransmitted commonly through food …
10 States, 2008
5.0% 0.9
4.60%
4.5% 0.8
4.03%
4.0%
3.61% 0.7
3.44%
Incidence per 100,000

3.5%
Percent Positive
0.6
3.02% 2.91%
3.0%
2.90%
2.54% 0.5
2.5% 2.25% National Health Objective:
0.4 0.24 Cases per 100,000
1.91%
2.0%
1.45% 0.3
1.5% 1.32%
1.03% 0.2
1.0% 0.76%
0.55% 0.64% 0.61%
0.43% 0.42% 0.1
0.5%
0.0% 0.0
1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
Calendar Year
Calendar Year
Why a plateau in listeriosis?

Where should we focus our efforts to further
reduce listeriosis?
Science, FSIS
• FSIS comparative Lm risk 2009 FSIS Comparative Lm Risk

Assessment: Pre-packaged vs. Retail-
assessment evaluated the risk of sliced Deli Meat
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 Source:
http://www.fsis.usda.gov/PDF/Comparative_
assessment to evaluate retail RA_Lm_Report.pdf
cross-contamination and Lm
controls
Using RA to Successfully Mitigate
Listeriosis in the U.S.
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
Lessons Learned

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

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
Future Direction

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
Contact Information

Science, FSIS
Janell Kause, Director

Risk Assessment Division
Office of Public Health Science
Food Safety and Inspection Service
U.S. Department of Agriculture
E-mail: Janell.kause@fsis.usda.gov
FSIS Risk Assessment Website:

www.fsis.usda.gov/Science/Risk_Assessments/index.asp

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