amr risk assessment (and risk analysis)
TRANSCRIPT
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Simon Otto, PhD DVM BScAssistant Professor
AMR Risk Assessment(and Risk Analysis)
We acknowledge and pay tribute to the traditional territories of the peoples of Treaty 6, which includes the Cree, Blackfoot, Métis, Nakota Sioux, Iroquois, Dene, Ojibway, Saulteaux, Anishinaabe, Inuit, and many others
whose histories, languages, and cultures continue to influence our vibrant community.
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My Research• One Health epidemiology
of antimicrobial resistance (AMR)
• AMR/antimicrobial use (AMU) surveillance; diagnostic testing
• Antimicrobial stewardship www.heat-amr.com
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Links to Course Learning Outcomes
• Course Learning Outcomes:1. Complex contributing factors to AMU and the
emergence and spread of AMR.4. The role of One Health in complex problems
and AMR.5. AMR surveillance requirements and mitigation
efforts.
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Learning Objectives (Outline)• Objective 1: Explain risk and the components of a Risk
Analysis (Risk Management, Communication and Assessment).
• Objective 2: Explain the process of an AMR Risk Assessment for foodborne pathogens.
• Objective 3: Describe the different types of models and risk assessments.
• Objective 4: Explain the different data sources that can feed into an AMR Risk Assessment.
• Objective 5: Assess why One Health is important for AMR Risk Assessment.
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Risk Analysis
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RISK ASSESSMENT
RISK MANAGEMENT
RISK COMMUNICATION
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Identification of an AMR food safety issue
Develop a risk profile
Rank the food safety issue for risk assessment/management priority
Establish preliminary risk management goals
Establish risk assessment policy and commission a risk assessment
Hazard Identification
Exposure Assessment Hazard Identification
Risk Characterization
Consider the risk assessment results
Implement risk management
decisions
Identify, evaluate, and select risk management
options
Monitor and review risk management measures
Risk
M
anag
emen
tRi
skAs
sess
men
tPr
elim
inar
y ris
k m
anag
emen
t act
iviti
es
Risk
Com
mun
icat
ion
Surv
eilla
nce
of A
MR
and
othe
r sou
rces
of i
nfor
mat
ion
Immediate/ provisional
decision
No action
Figure 1. Framework for Foodborne AMR Risk Analysis (Codex, CACGL 77-2011 guidelines).
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Risk Analysis vs Assessment
• Risk Analysis: three components• Foodborne AMR Risk Assessment:
– “Transparent, science-based approach to identify and assess a chain of events that affect the frequency and amount of AMR microorganisms to which humans are exposed through the consumption of food and to describe the magnitude and severity of the adverse [human] health effects from that exposure.”
The process of combining evidence to provide an estimate of risk and evaluate interventions
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FAO – Food Safety Risk AnalysisGuide
• Supplemental, broad reference for Food Safety Risk Analysis– 2007 FAO Food Safety Risk Assessment
guidelines– (The framework used by Codex)
http://www.fao.org/3/a0822e/a0822e.pdf
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Two Components of Risk?
1. Probability?
2. Severity?
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Risk Analysis• Risk is function of the:
1. Probability/likelihood of an adverse health event• e.g. prevalence of the foodborne hazard in the
food
+2. Severity of that event should it occur
• e.g. severity of the exposure to the hazard assuming it is in the food
• hazard and host factors
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Video for your info: https://www.youtube.com/watch?v=PZmNZi8bon8
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Analysis of Complex Systems
• Use of a “model” to represent the analysis of a complex system– What are the main characteristics?
• Iterative, evolving, integrated, dynamic– Parameters incorporate uncertainty into the
process (probabilistic vs deterministic)– Model allows for incorporation/integration of
diverse but related sub-systems
Javier Sanchez, UPEI, 2016
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Risk Analysis for Managing and Regulating Risks
• Regulation is a mechanism to control risk– Risk Management option (manufacturing,
processing, commercialization)– But they impose a societal cost and (ideally)
should be consistent with their risk reduction potential
– Risk Analysis provides tools to quantify the amount of risk reduction for each measure
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Risk Analysis
• Tool intended to provide decision-makers with an objective, repeatable and documented assessment of the risks posed by a particular course of action– What can go wrong?– How likely is it to go wrong?– Consequences?– What can be done?
Javier Sanchez, UPEI, 2016
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Risk Management• Weighing policy alternatives in consultation
with stakeholders• Consider the risk assessment and other
factors for consumer protection and promotion of fair trade
• Select optimal prevention and control methods to manage hazards and reduce risk
• Review the outcome• Goal: to protect public health
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Risk Analysis Frameworks
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Uncertainty and Variability
• Uncertainty: lack of data or incomplete understanding of data– Reduce with further measurement/study
• Variability: inherent heterogeneity in the data– Effect of chance; function of the system– Cannot reduce with more measurement– Reduce by changing the system
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Goals of AMR Risk Assessment
• Vary with objectives set by risk manager– Estimate of risks to human health from AMR
attributable to AMU in animals– Identify and incorporate uncertainty into risk
estimation and identify gaps in science– Investigate the consequence to animal health
and impacts of control strategies on the risk to public health
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Snary + McEwen, Ch. 3 AMR Risk Assessment, IN Guardabassi, Jensen, Kruse, “Guide to AMU in Animals”, 2008.
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Top-down vs Bottom-up• Bottom-up:Source farm-to-fork consumption outcomes• Adv: can evaluate risk management options• Disadv:
– Intensive (data, time, skills)– Data gaps uncertainty – may (not) be fixed
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Snary + McEwen, Ch. 3 AMR Risk Assessment, IN Guardabassi, Jensen, Kruse, “Guide to AMU in Animals”, 2008.
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Top-down vs Bottom-up• Top-down:
# human cases % attributable to source of interest– Notifiable diseases, epi studies
• Adv: simple (good and bad)• Disadv: biased data, attribution to specific
food source/animal, subjectivity– Cannot evaluate risk management options
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Snary + McEwen, Ch. 3 AMR Risk Assessment, IN Guardabassi, Jensen, Kruse, “Guide to AMU in Animals”, 2008.
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Identification of an AMR food safety issue
Develop a risk profile
Rank the food safety issue for risk assessment/management priority
Establish preliminary risk management goals
Establish risk assessment policy and commission a risk assessment
Hazard Identification
Exposure Assessment Hazard Identification
Risk Characterization
Consider the risk assessment results
Implement risk management
decisions
Identify, evaluate, and select risk management
options
Monitor and review risk management measures
Risk
M
anag
emen
tRi
skAs
sess
men
tPr
elim
inar
y ris
k m
anag
emen
t ac
tiviti
es
Risk
Com
mun
icat
ion
Surv
eilla
nce
of A
MR
and
othe
r sou
rces
of i
nfor
mat
ion
Immediate/ provisional
decision
No action
Figure 1. Framework for Foodborne AMR Risk Analysis (Codex, CAC/GL 77-2011 guidelines).
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Identification of an AMR food safety issue
Develop a risk profile
Rank the food safety issue for risk assessment/management priority
Establish preliminary risk management goals
Establish risk assessment policy and commission a risk assessment
Hazard Identification
Exposure Assessment Hazard Identification
Risk Characterization
Consider the risk assessment results
Implement risk management
decisions
Identify, evaluate, and select risk management
options
Monitor and review risk management measures
Risk
M
anag
emen
tRi
skAs
sess
men
tPr
elim
inar
y ris
k m
anag
emen
t ac
tiviti
es
Risk
Com
mun
icat
ion
Surv
eilla
nce
of A
MR
and
othe
r sou
rces
of i
nfor
mat
ion
Immediate/ provisional
decision
No action
Figure 1. Framework for Foodborne AMR Risk Analysis (Codex, CAC/GL 77-2011 guidelines).
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Identification of an AMR food safety issue
Develop a risk profile
Rank the food safety issue for risk assessment/management priority
Establish preliminary risk management goals
Establish risk assessment policy and commission a risk assessment
Hazard Identification
Exposure Assessment Hazard Identification
Risk Characterization
Consider the risk assessment results
Implement risk management
decisions
Identify, evaluate, and select risk management
options
Monitor and review risk management measures
Risk
M
anag
emen
tRi
skAs
sess
men
tPr
elim
inar
y ris
k m
anag
emen
t ac
tiviti
es
Risk
Com
mun
icat
ion
Surv
eilla
nce
of A
MR
and
othe
r sou
rces
of i
nfor
mat
ion
Immediate/ provisional
decision
No action
Figure 1. Framework for Foodborne AMR Risk Analysis (Codex, CAC/GL 77-2011 guidelines).
Codex, CAC/GL 63-2007
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Identification of an AMR food safety issue
Develop a risk profile
Rank the food safety issue for risk assessment/management priority
Establish preliminary risk management goals
Establish risk assessment policy and commission a risk assessment
Hazard Identification
Exposure Assessment Hazard Identification
Risk Characterization
Consider the risk assessment results
Implement risk management
decisions
Identify, evaluate, and select risk management
options
Monitor and review risk management measures
Risk
M
anag
emen
tRi
skAs
sess
men
tPr
elim
inar
y ris
k m
anag
emen
t ac
tiviti
es
Risk
Com
mun
icat
ion
Surv
eilla
nce
of A
MR
and
othe
r sou
rces
of i
nfor
mat
ion
Immediate/ provisional
decision
No action
Figure 1. Framework for Foodborne AMR Risk Analysis (Codex, CAC/GL 77-2011 guidelines).
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Identification of an AMR food safety issue
Develop a risk profile
Rank the food safety issue for risk assessment/management priority
Establish preliminary risk management goals
Establish risk assessment policy and commission a risk assessment
Hazard Identification
Exposure Assessment Hazard Identification
Risk Characterization
Consider the risk assessment results
Implement risk management
decisions
Identify, evaluate, and select risk management
options
Monitor and review risk management measures
Risk
M
anag
emen
tRi
skAs
sess
men
tPr
elim
inar
y ris
k m
anag
emen
t ac
tiviti
es
Risk
Com
mun
icat
ion
Surv
eilla
nce
of A
MR
and
othe
r sou
rces
of i
nfor
mat
ion
PROVISIONALdecision
No action
Figure 1. Framework for Foodborne AMR Risk Analysis (Codex, CAC/GL 77-2011 guidelines).
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Identification of an AMR food safety issue
Develop a risk profile
Rank the food safety issue for risk assessment/management priority
Establish preliminary risk management goals
Establish risk assessment policy and commission a risk assessment
Hazard Identification
Exposure Assessment Hazard Identification
Risk Characterization
Consider the risk assessment results
Implement risk management
decisions
Identify, evaluate, and select risk management
options
Monitor and review risk management measures
Risk
M
anag
emen
tRi
skAs
sess
men
tPr
elim
inar
y ris
k m
anag
emen
t ac
tiviti
es
Risk
Com
mun
icat
ion
Surv
eilla
nce
of A
MR
and
othe
r sou
rces
of i
nfor
mat
ion
Immediate/ provisional
decision
No action
Figure 1. Framework for Foodborne AMR Risk Analysis (Codex, CAC/GL 77-2011 guidelines).
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Identification of an AMR food safety issue
Develop a risk profile
Rank the food safety issue for risk assessment/management priority
Establish preliminary risk management goals
Establish risk assessment policy and commission a risk assessment
Hazard Identification
Exposure Assessment Hazard Identification
Risk Characterization
Consider the risk assessment results
Implement risk management
decisions
Identify, evaluate, and select risk management
options
Monitor and review risk management measures
Risk
M
anag
emen
tRi
skAs
sess
men
tPr
elim
inar
y ris
k m
anag
emen
t ac
tiviti
es
Risk
Com
mun
icat
ion
Surv
eilla
nce
of A
MR
and
othe
r sou
rces
of i
nfor
mat
ion
Immediate/ provisional
decision
No action
Figure 1. Framework for Foodborne AMR Risk Analysis (Codex, CAC/GL 77-2011 guidelines).
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Risk Assessment Policy
• What is the risk question?• Do’s
– Ensures the risk assessment is:• Systematic• Complete• Unbiased• Transparent
– Clear mandate from risk manager to address:• Scope? address uncertainty? Assumptions?
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Risk Assessment Policy
• Don’ts– Lack of transparency– Lack of clarity of scope or risk management
options– Scope creep– Ignores uncertainty– Does not state assumptions
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Commission a Risk Assessment
• Risk manager wants an evaluation of relevant scientific knowledge about an identified risk
• Goal:– To make an informed decision regarding
appropriate risk management activities
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Type of Model?
• Qualitative (low, medium, high)• Semi-quantitative (risk ranking)• Quantitative – mathematical models
– Most common today– Based in quantitative microbial risk
assessment (QMRA)• Accounts for population dynamics of the organism• What about AMR genes? See later
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Subjectivity?
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Stochastic vs Deterministic
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Hazard Identification
• Describe the foodborne AMR hazard• Literature and surveillance data
– Specific strains/genotypes of organism– Combination of organism with food product– AMR determinants (genes, plasmids)– Antimicrobial agents– Biology and niche-dependent differences
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AMU selecting for AMR*
Animal/crop and microbial factors affecting dissemination of AMR*
Other sources of AMR* for target animal/crop
Frequency/ concentration of AMR* at slaughter/ harvest
Consumer factors: freq/ conc at food consumption
Microbial factors: transfer and maintenance of AMR
Food processing factors: freq/conc of organism
Sele
ctio
n an
d di
ssem
inat
ion
of A
MR*
Expo
sure
to A
MR
from
con
sum
ptio
n of
Foo
d
Objective: estimate magnitude of human exposure to AMR* considering all relevant pathways/risk factors. AMR* = AMR
organisms or genes
ExposureAssessment
Figu
re 2
a. F
ram
ewor
k fo
r Foo
dbor
ne A
MR
Risk
An
alys
is (C
odex
, CAC
/GL
77-2
011
guid
elin
es).
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Exposure Assessment• Fundamental activities:
– Clear description of exposure pathway– Necessary data requirements– Summarise the data
• Factors to consider:– Pre-harvest factors (e.g., AMU frequency/
effect)– Processing factors– AMR gene transmission?
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Qualitative description
↑ treatment failures/ loss of treatment options
↑ severity of infection/ disease(prolonged disease, ↑ hospitalizations, ↑ mortality)
↑ frequency of infection/disease
Dis
ease
rela
ted
to p
atho
gens
Adve
rse
heal
th e
ffect
s rel
ated
to A
MR
Objective: estimate of the adverse health effects related to AMR conditional on infection and disease with an AMR organism or AMR gene.
Hazard Characterization
Figu
re 2
b. F
ram
ewor
k fo
r Foo
dbor
ne A
MR
Risk
An
alys
is (C
odex
, CAC
/GL
77-2
011
guid
elin
es).
Semi-quantitative models
Quantitative models
Options to translate exposure to AMR into probability of
infection and disease
Estimates of the further outcomes that can occur as a result of disease due to
AMR pathogens
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Hazard Characterization
• Translate the levels of exposure to likelihood of an array of adverse health events/outcomes– Determination of risk factors (for the hazard)– Defining the site/mechanism of action– Measuring the does-response relationship
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Hazard Characterization
• Risk outcome = disease from infection– Difference: specific focus on AMR organism– Complications from treatment failure or
increased severity attributable to AMR• May be informed by info from non-AMR
organisms– Lack of data for AMR organisms– Lack of methods for AMR organisms
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Dose-Response Models
• Develop relationship between level of microbial exposure and likelihood of occurrence of adverse event
• Challenges:– We don’t have experimental data for many
foodborne pathogens in humans– We don’t have AMR-specific data
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What about AMR C. jejuni?
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• Uses stochastic simple death processes and Markov chains to calculate total risk from exposure to susceptible and resistantpathogens based on original DRM
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Risk Characterization
• Form and outputs vary depending on risk management request (RA Policy)– Risk estimate– Evaluation of Risk Management Options– Characterize uncertainty/variability– Data gaps
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Hazard Identification
Exposure Assessment
Hazard Characterization
Risk Estimate
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Risk Characterization
• Other elements to consider:– Sensitive sub-populations– Key assumptions and impact on validity– Explicit explanation of variability/uncertainty– Sensitivity and uncertainty analysis– Strengths/weaknesses and limitations– Alternatives to be considered– Key conclusions
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Foodborne AMR Risk Management Options
• See Table 1 in Codex CAC/GL 77-2011 for more complete discussion
• Pre-harvest options– Animal feed, animal management (drug use),
crop production, waste management• Post-harvest options
– Prevent food contamination, microbial criteria
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Another Resource
• USFDA: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-152-evaluating-safety-antimicrobial-new-animal-drugs-regard-their-microbiological-effects
• Uses the OIE framework
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Some examples:
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https://doi.org/10.1016/j.ijfoodmicro.2020.108559
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Some examples:
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https://doi.org/10.1111/j.1539-6924.2006.00723.x
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Some examples:• USFDA, CVM, Vose D et al., 2000. Human Health
Impact of Fluoroquinolone Resistant CampylobacterAttributed to the Consumption of Chicken (https://www.fda.gov/media/76429/download)
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https://doi.org/10.1093/cid/ciu496
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Important Considerations
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https://doi.org/10.3389/fmicb.2019.01107
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Risk Communication• Happens throughout the risk analysis process
– Risk related factors– Risk perceptions
• Between/among:– Risk assessors– Risk managers– Consumers– Industry– Academia– Other stakeholders
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What is Risk Communication?
• Objective: create an informative and motivational dialogue about the nature and mitigation of a risk– Forestall a crisis– Lessen its impact
Cole & Fellows, Southern Communication Journal, 2008, 73:3, https://doi.org/10.1080/10417940802219702
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Risk Communication
https://www.youtube.com/watch?v=3lHGshTDMCw 55
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Why is risk communication so important? (and not just about science)
https://www.youtube.com/watch?v=cm0b3mknhAE – apologies for language! 56
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Summary• Risk and Risk Analysis
– Risk Management, Assessment and Communication
• Process of AMR Risk Assessment• Types of models, top-down vs bottom-up• Data sources for risk assessment• One Health considerations
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Thank you!
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Discussion Question
1. What are the possible information sources for identification of AMR food safety issue and to inform an AMR risk assessment?
2. Why is it important to use a One Health lens for data sources for AMR Risk Assessment?
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