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St k h ld P ti E iStakeholders Perspective on Emerging Risks
John O’BrienNestlé
EFSA Scientific Colloquium on Emerging Risks in Food: from Identification to Communication, 12‐13 October 2010
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Complexity: Number of chemical substances
• CAS (Chemical Abstracts Service) Database– organic inorganic & biosequence substanceorganic, inorganic & biosequence substance
information• CAS registry numbers
– unique – can be validated quickly and reliably – internationally recognized
• registry of substances 1957- present – some going back to early 1900s– ~ 12,000 new substances added per day
55 illi i i d i i– 55 million unique organic and inorganic substances listed (Oct 2010)
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Complexity: CAS registrations 1965-2008
40,000,000
45,000,000
30 000 000
35,000,000
25,000,000
30,000,000
ubst
ance
s
15,000,000
20,000,000
No.
su
5,000,000
10,000,000
0
1965
1966
1967
1968
1969
1970
1971
1972
1973
1974
1975
1976
1977
1978
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
Year
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Complexity: Regulations & Global Trade
600
World food exports (billions US$)
500
400
300
2001990 1992 1994 1996 1998 2000 2002 2004
Source: Food and Agriculture Organization of the United Nations
- 1 000 maximum limits for food additives and contaminants3 000 i id li it f ti id d t i d
More than:
4
- 3 000 maximum residue limits for pesticides and veterinary drugsSource: Codex Alimentarius Commission
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Factors influencing the emergence of new food risks
• Growing complexity of the global food supply• Differences in regulatory controls throughout the global supplyDifferences in regulatory controls throughout the global supply
chain• Longer supply chains and more rapid distribution • Fluctuations in commodity prices• Developments in analytical science• Consumer demands• Consumer demands • Differences in consumer vulnerability to foodborne hazards• Growth in use of agricultural land for other uses (eg crops for
biofuels, pharmaceuticals)• Climate change• Differences between risk perception by groups in society and• Differences between risk perception by groups in society and
scientific risk assessment
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Pitfalls in the handling of emerging risks and food safety incidents
• Limited data availability and quality• Differences in problem formulationDifferences in problem formulation• Time required to conduct risk assessments• Differences in risk management and communication• Possibility of risk management decisions driven by available
data in advance of analysis of data suitability, strengths, weakesses, gapsweakesses, gaps
• Possibility of undue weighting given to hazard data• Imbalance in the pace of developments in risk analysis and
new analytical science tools• Gaps in harmonization of analytical methods
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Horizon Scanning: Two caveats
1. Information is not knowledgeEinstein
2 The illusion of understanding how everyone thinks he knows2. The illusion of understanding..how everyone thinks he knows what is going on in a world that is more complicated than they realize.
Taleb, in the Black Swan
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Industry measures to address emerging risks
• Early warning systems: awareness through expert networks,Early warning systems: awareness through expert networks, literature and web scanning and communication with buyers, suppliers, othersTargeted surveillance programmes• Targeted surveillance programmes
• Targeted research projects• RASFF and other alerting toolsRASFF and other alerting tools• Food Safety Management Plans• Trade association working groups
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Handling of Emerging Risks: Industry activities (CIAA)
• Food Safety Management Group• Incident Management Group• Food Safety Platform
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CIAA Incident Management Group
• Only food safety risks • Only industry-wide issues (not single company)Only industry wide issues (not single company)• Emerging issues when there are limited data and in the
absence of specific regulations• Consumer/media perceived risk• Rapid response (within 48 hours)• Communication with the European commission and other• Communication with the European commission and other
public bodies
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Scientific tools for rapid assessment of emerging risks
• Qualitative and (semi)-quantitative approaches such as TTC MOEsuch as TTC, MOE,
• Computational toxicology and quantitative microbiology toolsmicrobiology tools
• Risk-Risk and Risk-Benefit assessments where appropriatepp p
• Hazard-based high-throughput in-vitro screens• New analytical technologyy gy
• GOAL: BETTER/FASTER MANAGEMENT OF RISKS
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Early Warning Principles
mpa
ctIm
Time
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Early Warning Process
mpa
ctDetect
Im Understand
Risk evaluationEarly Warning
Communicate
CorporateCorporateDecisions
ActionsR&D & QM
Time
R&D & QM
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EW Network
EW Core Team
Packaging
Nutritionists
Agriculture Packaging
Expertsservices
C t i tContaminant experts R&D specialistsEWCT
RegulatoryAffairs
T i l i t
Microbiologists
NRC/QS
Toxicologists
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New Technology: e.g. Multiscreening by TFC-MS/MS
er79 Analytes spiked at 50 μg/L
MONITORED FAMILIESAMINOGLYCOSIDESBETA LACTAMS
pow
de • Analysis of 79 veterinary drug compounds belonging to 8 families of antibiotics
BETA- LACTAMSCEPHALOSPORINSMACROLIDESQUINOLONESSULFONAMIDESTETRACYCLINESANTIMICROBIAL FEED AGENTed
milk • Screening at MRPL 4-10 μg/L
for a large majority of analytes and 100-200 μg/L for
ANTIMICROBIAL FEED AGENTMISC.ANTIMICROBIAL AGENT
Skim
me
aminoglycosides
■ Validation according to EU recommendations: Commission Decision 2002/657/EC■ Validation according to EU recommendations: ‐ Commission Decision 2002/657/EC‐ CRL Guidelines 2010
■ Positive samples confirmed in a second injection (standard addition)
■ Method applicable to skimmed milk powder and infant formula
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Golden Rules
• Networking to understand food chain vulnerabilities• Ensure access to necessary risk assessment and• Ensure access to necessary risk assessment and
analytical expertise• Application of validated FSMPs ensuring• Application of validated FSMPs ensuring
compliance with current standards• Verification programmes including supplier auditsVerification programmes including supplier audits• Prompt review/root-cause analysis of incidents
coupled with continuous improvement programmes p p p g• Targeted contaminant surveillance plans
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Emerging Risks: Challenges
• Risk Communication • Difficulty to prioritize food safety concerns (absence
of tools, acceptability of approaches)• Ensuring risk managment measures proportionate
to risk• On-going lack of harmonization of approaches
internationallyAb f f d f t l ti t i• Absence of food safety alerting systems in many regions of the world
• Limited food consumption data for many regions of• Limited food consumption data for many regions of the world
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An ounce of prevention is worth a pound of cure
Benjamin Franklin