Risk assessments on
Transcript of Risk assessments on
Risk assessments on
Enterobacter sakazakii
(Cronobacter spp.) in
powdered infant formula
and follow-up formula
Sarah Cahill
Nutrition and Consumer Protection Division
Food and Agriculture Organization of the United Nations, Rome, Italy
Outline
� JEMRA
� E. sakazakii (Cronobacter spp.) in the
international standard setting arena
� International risk assessment work
� Outputs
� Conclusions
International
risk assessmentJECFA, JMPR, JEMRA,
ad hoc expert
consultations
Member Countries
Data, expertise
Scientific
advice
WTO Agreements
Benchmark
standards
Scientific
advice
International trade agreementsStandards,
guidelines,
related texts
Requests for
advice, risk
assessment
Needs,
feasibility,
inputs, etc.
International risk managerCODEX
ALIMENTARIUS
JEMRA
E. sakazakii (Cronobacter
spp.) in the international standard setting arena
� Urgency� High mortality in infants� Issue raised by countries in Codex meetings, World Health
Assembly
� Powdered infant formula (PIF) meeting the existing international/Codex standards implicated in cases of illness� Did not specifically address E. sakazakii
� How?
� micro criteria?� guidance for manufacturers?
� guidance for users?→ Needed a review of the science
→ Questions for the risk assessment
Challenges in undertaking an
international risk assessment
� Diversity in product and production systems
� Differences in preparation and use of product, exposure
� But
� Very specific product focus
� Product in international trade - from one plant product goes to many different countries
� Increased value of a global approach
Risk assessment
� 4 years (2003 – 2007)
� 35 + experts
� Review of scientific literature and approx 56 data submissions from around the world (national authorities, industry, academia, consumers)
� Initial focus – PIF, then FUF
Direct outputs
� 3 published reports (MRA 6, 10, 15)
� web-based risk assessment tool
Risk assessment in an
evolving environment
� 2003 – a handful of groups working on this organism 2009 – international conference
� Detection methods – evolving
� Sources of organism
� Evolving taxonomy – 2008 name change E. sakazakii to Cronobacter spp.
� Geographic extent of problem (lack of surveillance means this is still a limitation)
Impact on approach and
model design
� Flexibility
� Capable of coping with changes in
data or different data sets
� Facilitate “live” or “real-time” use and
rapid assessment of a range of
scenarios
Other challenges to model
development
� Lack of information on dose- response
� assumption that illness results from
presence of 1 cfu per serving in dry
PIF at time of preparation
� Focus on relative risk rather than
absolute risk
Other challenges to model
development
� Lack of information on variations in
preparation, storage and use of PIF
� survey undertaken by international
consumer body which identified the
variations that exist
� Information on preparation and use to
be input by the user of the model
Dose per ServingDose per Serving
DeclineDecline GrowthGrowth
Concentration In powder supply
Concentration In powder supply
Temperature of PIFTemperature of PIF
Number of CasesNumber of Cases
Impact of sampling plan
Impact of sampling plan
Concentration in powder supply
Concentration in powder supply
Relative RiskRelative Risk
Initial concentration
Initial concentration
Dose per servingDose per serving
Probability of illnessper contaminated serving
Probability of illnessper contaminated serving
Number of contaminatedservings
Number of contaminatedservings
Preparation scenarioPreparation scenario
Total PIF Consumption
Total PIF Consumption
Formula requirements
Formula requirements
Powder consumption
Powder consumption
Infant weightInfant weight
www.mramodels.org
What has this work allowed
us to do?
� Review of data
� PIF
� FUF
� Application of model
� PIF
Categorization of
microorganisms of concern
Cases of specified illness in infants
Identified pathogensConsumption of PIF
Salmonella
E. sakazakii
Category B
Pantoea agglomerans and
Escherichia vulneris
Hafnia alvei,
Klebsiella pneumoniae,
Citrobacter koseri,
Citrobacter
freundii,
Klebsiella oxytoca,
Enterobacter cloacae,
Escherichia coli, Serratia
spp. and Acinetobacter
spp.
Category C
Bacillus cereus, Clostridium difficile,
Clostridium perfringens, Clostridium
botulinum, Listeria monocytogenes,
Staphylococcus aureus and
coagulase-negative
staphylococci
Definition of at risk groups
� ~120 individually documented cases
among infants and young children < 3
years of age
� majority in <2 month olds
� 6 cases – 6 to 11 month age group
� 2 cases – 12 to 36 month age group
Definition of at risk groups
� Invasive cases in all age groups
� but infants at particular risk &
� neonates and infants under 2 months at greatest risk
� Caveats
• data from developed countries
• impact of an increase of risk factors which compromise immune system – definition may have to change
� Risk management implications
� focus on products for groups at greatest risk (PIF)
� how to address products for older infants (follow-up formula)
What has this allowed us to
do?
� Inform the revision of the Codex recommended code of hygienic practice – Adopted in 2008
� Establishment of new end product criteria for PIF
� Enterobacter sakazakii (Cronobacter species) n =30 c=0 m=0/10 g (2 class plan)
� Salmonella n=60 c=0 m=0/25 g
� Process hygiene criteria
Mesophilic Aerobic Bacteria c=5 n=2 m=500/g M=5000/g (3 class)
Enterobacteriaceae c=10 n=2 m=0/10 g (2 class)
Follow-up formula
� no clear scientific justification either for or against establishing a micro criterion for E. sakazakii in FUF
� Risk management outcome � No criteria established but if evidence in a
particular country of increased risk apply criteria for PIF
� Increased emphasis on consumer education re use of this product
� Encourage more data collection to clarify situation
What has this allowed us to
do?
� Highlight the impact in variations of
consumer practices
� important role of consumers
� need for education
� Greater emphasis on this in the
revised Codex guidelines
� Additional guidance by WHO and
FAO
Development of risk based
guidelines for the safe preparation, storage and use of PIF
Facilitated by the collaboration of
FSAI
Summary & conclusions
� E. sakazakii / Cronobacter heralded a new approach for addressing an emerging pathogen in an
� Communication and collaboration with and among research and academic community and industry
� Risk managers need to be the drivers of the risk assessment process
� Value of international risk assessment
� flexibility is key
� only as good as the decisions it allows risk managers to make (need to be a step ahead of risk managers)
� Conversion of risk assessment outputs into something practical...e.g. targeted guidance documents
Acknowledgements
Experts
Colin Block
Anna Bowen
Chris Braden
Robert Buchanan
Celia Carlos
Verna Carolissen
Bernard Coignard
Martin Cole
Paul Cook
John Cowden
Donald Campbell
Jean-Louis Cordier
Alexander Cravioto
Sue Dobson
Sri Estuningsih
Séamus Fanning
Jeffrey Farber
Aamir Fazil
Sara Fein
Stephen Forsythe
Mary Friel
Emma Hartnett
Arie Havelaar
Shizunobu Igimi
Judith Kellls
Daniel March
Jeronimas Maskeliunas
Harry Muytjens
Gopinath Balakrish Nair
Lisa Lefferts
Greg Paoli
Hildegaard Przyrembel
Alan Reilly
Caroline Smith Dewaal
Firdausi Qadri
Juliana Ruzante
Hajime Toyofuku
Jos Van Acher
Kaye Wachsmuth
Donald Zink
Marcel Zweitering
� Data providers (NGOs, Academic institutions, industry, National authorities)
� Resource providers (financial or in kind) –FAO, WHO, US, Japan, FSAI, FDA-CFSAN
� FAO and WHO – Maria de Lourdes Costarrica, Peter KarimBenEmbarek