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

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)

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

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

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

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

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

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

Handling of Emerging Risks: Industry activities (CIAA)

• Food Safety Management Group• Incident Management Group• Food Safety Platform

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

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

Early Warning Principles

mpa

ctIm

Time

Early Warning Process

mpa

ctDetect

Im Understand

Risk evaluationEarly Warning

Communicate

CorporateCorporateDecisions

ActionsR&D & QM

Time

R&D & QM

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

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

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

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

An ounce of prevention is worth a pound of cure

Benjamin Franklin