Food Safety Risk Assessment Policies and Procedures at the - - PowerPoint PPT Presentation
1 W e d n e s d a y, A p r i l 2 4 , 2 0 1 9 0 9 : 0 0 A M - 0 9 : 3 0 A M Food Safety Risk Assessment Policies and Procedures at the US-FDA,EFSA and ANSES Moez SANAA ANSES: French Agency for Food, Environmental and Occupational
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W e d n e s d a y, A p r i l 2 4 , 2 0 1 9 0 9 : 0 0 A M - 0 9 : 3 0 A M
Moez SANAA ANSES: French Agency for Food, Environmental and Occupational Health & Safety Department of Risk Assessment Head of Food Safety Risk Assessment Unit
2009-2017 Risk Assessment Methodology Food Safety Risk Assessment 2006-2012: AHAW panel 2012-2018: BIOHAZ panel 2017-2018: Senior scientist Food Safety Risk Assessment
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Assessment Communication Management
R i s k B a s e d F o o d S a f e t y S y s t e m
R i s k a n a l y s i s i s u s e d t o d e v e l o p a n e s t i m a t e o f t h e r i s k s t o h u m a n h e a l t h a n d s a f e t y , t o i d e n t i f y a n d i m p l e m e n t a p p r o p r i a t e m e a s u r e s t o c o n t r o l t h e r i s k s , a n d t o c o m m u n i c a t e w i t h s t a k e h o l d e r s a b o u t t h e r i s k s a n d m e a s u r e s a p p l i e d .
Scientific advice and information analysis.
R i s k A s s e s s m e n t
Regulations and controls
R i s k M a n a g e m e n t
Dialogue with all stakeholders
R i s k C o m m u n i c a t i o n
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Reformulate the risk questions Assemble the needed data Risk management, trade-offs and judgements of acceptability
Risk management framing assumptions: “risk assessment policy” Public consultancy, peer review,…
D e f i n e r e s p o n s i b i l i t i e s
Ex plicit ris k as s es s m en t po licy : ch o ice o f as ked qu es t io n s , w h at s h o u ld ex pert s as s es s (ris k, balan ce bet ween ris k an d ben efi t s , wh at co u n t s as relevan t eviden ce, pro cedu res o f t h e co llect ive ex pert is e, h o w m u ch eviden ce, an d wh ich kin ds , is n eces s ary o r s u fficien t fo r decis io n s abo u t accept an ce, reject ion o r res t rict io n s ? , wh at is t h e accept able level o f pro t ect io n ? , h o w s h o u l d u n cert ain t ies be addres s ed? ...
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F D A - C F S A N
F D A i s r e q u i r e d t o d o r i s k a s s e s s m e n t w h e n m a k i n g m a j o r f o o d s a f e t y p o l i c y d e c i s i o n s
E F S A
M o s t o f E F S A ’ s w o r k i s u n d e r t a k e n i n r e s p o n s e t o r e q u e s t s f o r s c i e n t i f i c a d v i c e f r o m t h e E u r o p e a n C o m m i s s i o n , t h e E u r o p e a n P a r l i a m e n t a n d E U M e m b e r S t a t e s .
A N S E S
M o s t A N S E S ’ s w o r k i s u n d e r t a k e n i n r e s p o n s e t o r e q u e s t s f o r s c i e n t i f i c a d v i c e f r o m t h e F r e n c h g o v e r n m e n t ( M i n i s t r i e s f o r h e a l t h , l a b o r , e n v i r o n m e n t , e c o n o m y a n d c o n s u m e r a f f a i r s , a n d a g r i c u l t u r e )
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R i s k A s s e s s m e n t
M u l t i d i s c i p l i n a r y
Micro bio lo gy , epidem io lo gy , s t at is t ics , ch emicals, mat h emat ical m o dels , fo o d t ech n o lo gy , …
C o n t r a d i c t i v e d e b a t e s
Co n s en s u s P o s s ibilit y o f Min o rit y Opin ion
N o C o n f l i c t o f i n t e r e s t
Declarat io n o f in t eres t pu blicly available Deo n t o lo gy co m m it t ee
P r o c e d u r e s F r a m e w o r k s
S OP s R is k as s es s m en t referen ce do cu m en t s , gu idan ce
ANSES and EFSA perform independent and multidisciplinary scientific assessments through their expert committees
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P R O C E D U R E S
ANSES received ISO 9001 certification since 2013.
Presentation of the
stakeholders
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select risk assessments.
assessment within a risk analysis framework.
used for risk assessments and specify what information is needed.
and supporting data developed by stakeholders and submitted to the CFSAN.
assessments dedicated workspace.
Initiation and Conduct of All "Major" Risk Assessments within a Risk Analysis Framework (2002)
Risk assessment
i.e., modelers
Communication
for internal processes
and external communication to public and stakeholders
Risk management
e.g., policy-makers
request risk assessment
for policy decisions
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H A R M O N I Z A T I O N
Seeking the consistency of the scientific opinions procedures and harmonization of working methods
Evaluate and synthetize data from different studies
S y s t e m a t i c R e v i e w
Statistical vs biological significance
B i o . S i g n i f i c a n c e
Use of the MOE concept in risk characterization
M a r g i n o f E x p o s u r e
Evaluate and combine different lines of evidence
W e i g h t o f E v i d e n c e
Bench mark Dose
B M D
Risk assessment approach adapted to nanoparticles in food
N a n o t e c h n o l o g y
Describe, analyze uncertainties at all steps of risk assessment
U n c e r t a i n t y
A company is an association
Te r m i n o l o g y
Risk assessment methodology for animal welfare
A n i m a l W e l f a r e
Use of whole genome sequencing in the food chain
W G S
Expert Elicitation Knowledge base on reproducible process
E K E
How to handle censured data in exposure assessment step?
E x p o s u r e A s s .
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S c i e n t i f i c a d v i c e b a s e d o n
Hazard Identification Hazard Characteri- zation Risk Characteri- zation Exposure Assessment C a u s a t i v e A g e n t a n d f o o d v e h i c l e E s t i m a t e t h e r i s k Metrics: DALY, Incidence, Probabilities, … D O S E - R e s p o n s e A s s e s s e x p o s u r e d o s e s
30% 60%
How often and how much of the contaminant is ingested? Likelihood of adverse effect relative to amount ingested Probability that adverse effect will occur. Predicted impact of various interventions on risk
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S c i e n t i f i c A s s e s s m e n t
In 1902, Harvey Washington Wiley organized a volunteer group of men called, Poison Squad, tested adulterated foods on themselves
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I n t e g r a t i o n
W e i n t e g r a t e d i v e r s e s c i e n t i f i c i n f o r m a t i o n a n d e v i d e n c e i n t o m a t h e m a t i c a l m o d e l s t h a t b e c o m e a f a v o r i t e t o o l t o a d d r e s s t h e r i s k m a n a g e m e n t r e q u e s t s
I n t e g r a t e i n f o r m a t i o n Simulate Scenarios Compare interventions Monitoring Plan optimization E s t i m a t e c a s e s o f i l l n e s s R a n k f o o d b o r n e r i s k s O p t i m i z e d e c i s i o n s
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I n t e g r a t i o n
Des cribes m at h em at ically t h e fo o d ch ain det erm in an t s , h az ard ch aract eris t ics , co n s u m er co n s u m pt io n pat t ern s an d s u s cept ibilit y .
https://irisk.foodrisk.org
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H o w o f t e n a r e w e u s i n g t h e Q R A a p p r o a c h ?
Biohaz panel(EFSA), BioRisk panel (ANSES), Risk Assessment Branch (FDA)
2015 onward
3/20 11/16 9/12
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E x a m p l e s
Egg Safety
EFSA: QRA in 2015
Salmonella on tree nuts
FDA: A Quantitative Assessment of the Risk of Human Salmonellosis Arising from the Consumption of Almonds in the United States: The Impact of Preventive Treatment Levels (JFP, 2017) and in Pecans (JFP, 2017)
Listeria monocytogenes in RTE foods
EFSA: QRA in 2018 FDA: Risk Ranking in 2003.
Foodborne pathogens in dairy
FDA/Health Canada: Listeriosis QRA from soft-ripened cheese consumption in the US and Canada (2015) EFSA 2015: Raw milk risk profile ANSES 2018: QRA was used to assess reblochon remarketing protocol after 2018 HUS outbreak in France QRA Salmonella Dublin outbreak prevention
Norovirus in shellfish
FDA/Health Canada: QRA Evaluating impact of practices and controls on risk of norovirus illness in humans from the consumption of oysters, clams and mussels
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Campylobacter in poultry
ANSES 2018: update knowledge about Campylobacter in broilers and chicken products, strategies for controlling the risk posed by the contamination and their
Salmonella in pork
ANSES 2018: Salmonella control measures in pork
Ground beef
ANSES 2017 and 2018: QRA
consumption of ground beef in France.
Trichinella spp. In Raw deli products
ANSES 2016: QRA of trichinellosis infection from the consumption of traditional deli products produced in Corsica. Including the development
Anti-microbial Resistance
EFSA 2018: Outcome indicators for the surveillance of AMR in humans and food- producing animals
E x a m p l e s
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M O D E L S
Data, Models and tools needs. P r i m a r y p r o d u c t i o n F o o d p r o c e s s i n g R e t a i l C o n s u m p t i o n
Agent release
models Processing Models X contamination Growth Survival Transfers Supply models Consumer Phase Models Including dose response models
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R i s k R A N K I G
in the context of US FSMA sect. 204 and CIMAP in France
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D e c i s i o n A n a l y s i s
Objective: reduce food borne illnesses impacts Public Health Incidence Severity Cost COI Trade Prevention Consumer Food production Primary production Interv. Efficacy Point of application Endpoint Sustainability Interv. Practicality
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S o u r c e A t t r i b u t i o n
ANSES critical revue of source attribution methods
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Resources for harmonized annotation and efficient exchange of risk assessment models
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S h a r i n g
P r i m a r y p r o d u c t i o n F o o d p r o c e s s i n g R e t a i l C o n s u m p t i o n
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