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 Health & Safety Department of Risk Assessment Head of Food Safety Risk Assessment Unit 2009-2017 2006-2012: AHAW panel 2017-2018: Senior scientist Risk Assessment Methodology 2012-2018: BIOHAZ panel Food Safety Risk Assessment Food Safety Risk Assessment

2 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 Risk Analysis 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 . R i s k A s s e s s m e n t Scientific advice and information analysis. Assessment R i s k M a n a g e m e n t Regulations and controls Management Communication R i s k C o m m u n i c a t i o n Dialogue with all stakeholders

3 D e f i n e r e s p o n s i b i l i t i e s Risk ANALYSIS ACTIVITIES AND RESPOSABILITIES 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? ... Request Societal – economic and Risk management framing assumptions: “risk assessment policy” Communication political factors Expert Assessment Scientific factors Reformulate the risk questions Assemble the needed data Communicate the Scientific Assessment Public consultancy, peer review,… Policy decision Technical, economic, Risk management, trade-offs and societal and political factors judgements of acceptability

E F S A 4 Scientific excellence Openness Transparency Independency Innovation 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 F D A - C F S A N Ex c ellenc e - Sc ientific ex pert is e Objec tiv ity Independenc y Relev anc e I mpart ialit y Bas ed on Sc ienc e Trans parenc y Transparency Ac c es s t o s t ak ehol der s 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 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 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 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 d e c i s i o n s 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 )

5 R i s k A s s e s s m e n t Scientific panels ANSES and EFSA perform independent and multidisciplinary scientific assessments through their expert committees M u l t i d i s c i p l i n a r y C o n t r a d i c t i v e d e b a t e s Micro bio lo gy , Co n s en s u s epidem io lo gy , s t at is t ics , P o s s ibilit y o f Min o rit y ch emicals, mat h emat ical Opin ion m o dels , fo o d t ech n o lo gy , … N o C o n f l i c t o f i n t e r e s t P r o c e d u r e s F r a m e w o r k s Declarat io n o f in t eres t S OP s pu blicly available R is k as s es s m en t referen ce Deo n t o lo gy co m m it t ee do cu m en t s , gu idan ce

6 P R O C E D U R E S Expertise organization in ANSES ANSES received ISO 9001 certification since 2013. Initial scientific Assigned to the domain- assessment by specific risk assessment unit rapporteurs or an ad hoc (expertise contract) working group REQUEST Presentations and exchanges with the scientific panel (s) Registration Validation of the Publication of the scientific opinion by the opinion scientific panel (Signed by GD) Presentation of the opinion to the stakeholders

7 1. Identify the issue, Initiation and Conduct of All "Major" Risk request risk assessment Risk assessment Risk management Assessments within a Risk Analysis i.e., modelers e.g., policy-makers Framework (2002) 2. Results provide info for policy decisions 1. Adopt a decision-based approach to identify and select risk assessments. Communication 2. Establish a procedure for the conduct of risk for internal processes assessment within a risk analysis framework. and external communication to public and stakeholders 3. Develop criteria to evaluate the quality of data used for risk assessments and specify what information is needed. 4. Develop guidelines to evaluate risk assessments and supporting data developed by stakeholders and submitted to the CFSAN. 5. Formalize a peer review process. 6. Build capacity to conduct complex risk assessments dedicated workspace.

8 H A R M O N I Z A T I O N EFSA GUIDANCE DOCUMENTS Seeking the consistency of the scientific opinions procedures and harmonization of working methods S y s t e m a t i c R e v i e w W e i g h t o f E v i d e n c e U n c e r t a i n t y Evaluate and synthetize data Evaluate and combine Describe, analyze from different studies different lines of evidence uncertainties at all steps of risk assessment B i o . S i g n i f i c a n c e B M D Te r m i n o l o g y Statistical vs biological Bench mark Dose A company is an association significance or collection of M a r g i n o f E x p o s u r e N a n o t e c h n o l o g y A n i m a l W e l f a r e Use of the MOE concept in Risk assessment approach Risk assessment risk characterization adapted to nanoparticles in methodology for animal food welfare W G S E K E E x p o s u r e A s s . Use of whole genome Expert Elicitation Knowledge How to handle censured data sequencing in the food chain base on reproducible process in exposure assessment step?

9 S c i e n t i f i c a d v i c e b a s e d o n Risk Assessment C a u s a t i v e A g e n t Likelihood of adverse effect relative to amount ingested D O S E - R e s p o n s e a n d f o o d v e h i c l e Hazard Hazard Characteri- Identification zation Probability that adverse effect will occur. Predicted impact of various interventions on risk Risk 30% Exposure Characteri- Assessment 60% zation E s t i m a t e t h e r i s k A s s e s s e x p o s u r e d o s e s Metrics: DALY, Incidence, How often and how much of the Probabilities, … contaminant is ingested?

10 S c i e n t i f i c A s s e s s m e n t Risk Assessment The “Poison Squad” In 1902, Harvey Washington Wiley organized a volunteer group of men called, Poison Squad, tested adulterated foods on themselves

11 I n t e g r a t i o n Today Risk Assessment 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 Simulate Scenarios E s t i m a t e c a s e s o f i l l n e s s Compare interventions R a n k f o o d b o r n e r i s k s I n t e g r a t e i n f o r m a t i o n Monitoring Plan optimization O p t i m i z e d e c i s i o n s

12 I n t e g r a t i o n Quantitative Risk Assessment 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

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 ? 13 Published Scientific opinion/Risk Assessments Biohaz panel(EFSA), BioRisk panel (ANSES), Risk Assessment Branch (FDA) 2015 onward 9/12 3/20 11/16

14 E x a m p l e s Microbial Risk Assessment Egg Safety Salmonella on Listeria monocytogenes Foodborne pathogens Norovirus in tree nuts in RTE foods in dairy shellfish FDA: A Quantitative EFSA: QRA in 2018 FDA/Health Canada: Listeriosis EFSA: QRA in 2015 FDA/Health Canada: QRA Assessment of the Risk of FDA: Risk Ranking in 2003. QRA from soft-ripened cheese Evaluating impact of Human Salmonellosis consumption in the US and practices and controls on Arising from the Canada (2015) risk of norovirus illness in Consumption of Almonds in EFSA 2015: Raw milk risk profile humans from the the United States: The ANSES 2018: QRA was used to consumption of oysters, Impact of Preventive assess reblochon remarketing clams and mussels Treatment Levels (JFP, 2017) protocol after 2018 HUS outbreak and in Pecans (JFP, 2017) in France QRA Salmonella Dublin outbreak prevention