Dealing with uncertainty in decision making – A Government

perspectiveDr Andrew Wadge

Chief Scientist

Food Standards Agency

12th annual joint Fera/JIFSAN

symposium

17 June 2011

Role of FSA• Risk assessment, management and

communication• Consumer protection: food safety and

associated labelling• Effective risk based

regulation/enforcement• Evidence gathering is commissioned

to underpin FSA functions – research, surveys, social science

Risk Assessment

• Importance of the evidence base – risk assessment as the starting point for risk management process

• Based on evidence from the scientific literature and work commissioned by the FSA.

• Risk assessments are carried out by in-house scientists with the support and challenge of independent scientific advisory committees.

• These in-house scientists are integral to the teams developing and implementing policy

Managing Risks Far wider evidence bases need to be

considered, not only the science It’s about judgement, but accountable

through open, transparent processes Regulation not always the answer Respect the reality of concerns even

when not supported by the evidence

Trust in the FSA

•Trust in FSA has gradually risen

% %

• © Press Association

Bisphenol A 2010 EFSA Conclusions

• Overall no new study identified that calls for revision of the current TDI of 0.05 mg/kg bw/day

• Uncertainties• Some studies on developing animals suggested other

effects of possible toxicological relevance• Studies had many shortcomings• Relevance for human health cannot be assessed

• Minority opinion from one member• Because of uncertainties TDI should be considered

temporary rather than full• No proposal for this or additional uncertainty factor as

methodological shortcomings in studies• Greatest exposure is for infants and could be reduced by

avoiding polycarbonate bottles

WHO/FAO November 2010

• For many end-points, there is no health concern. • Studies on developmental and reproductive toxicity

– Where conventional end-points were evaluated have shown effects only at high doses, if at all.

• However, for some emerging new end-points (sex-specific neurodevelopment, anxiety, preneoplastic changes in mammary glands and prostate in rats, impaired sperm parameters) associations at lower levels in a few studies .

• Considerable uncertainties – these should drive the direction of future research

Regulatory action in EUDenmark and France March 2010

announced ban on use of BPA in products intended for use by infants and children up to 3 years old and ban on BPA in infant feeding bottles

EFSA’s opinion of September 2010

European Commission November 2010EU Directive 2011/8/EU to restrict the use of BPA in polycarbonate infant feeding bottles

Precautionary approach based on the uncertainties described in the EFSA opinion, Since it could not be excluded that there might be effects on development, the immune response or tumour promotion;

 How and why is GM different to other issues

related to food safety and food production?

Is it actually different to other issues?

Evidence-based policies for a values-based public?

GM food

Attitudes to innovation in food production

2009 review of published studies on attitudes to a range of new and emerging technologies:

Our specific research projects have examined attitudes to:

Nanotechnologies Functional foods Synthetic biology

GM food and cropsAnimal cloning

IrradiationNovel food processes

Animal cloning(March 2008)

GM foods(November 2009)

Nanotechnologies(April 2011)

Typical responses to innovation

• is it safe?

• what’s in it for me?

• what’s in it for “them”?

• will it harm the environment?

• what about the welfare of animals?

• is it natural?March 2009 “An Evidence Review of

Public Attitudes to Emerging Food Technologies”

Attitudes to GM food 

findings included:

• 53% are undecided when asked “Do risks outweigh the benefits?” – some are disinterested but others want information to help them

decide

• Limited understanding of complex science means people make judgements based on their values – “emotional” responses?

• the public intuitively expect more / different safety studies than do risk assessors– e.g. clinical trials & long-term feeding studies

(British Social Attitudes Survey 2008-9)

Can science provide a better answer?

• risk assessment– more rigour in risk assessment– more openness– more independence– more consultation– better explanation, to a wider audience

• general information about the technology

How can/do policymakers engage with concerns about GM food production?

• consumer safety• environmental impact

– e.g. superweeds, diversity, changes to agricultural practices• economic impact

– does it put the interest of multinationals above those of small scale producers?

– will it benefit / disadvantage people in poorer countries?• moral and ethical dimensions

– moving away from nature• motives of the innovators (and regulators)

– why are they doing this to me, and the planet? – what’s in it for me?

Outbreaks in the UK linked to sprouted seedsYear Pathogen(s) No ill Vehicle

1988 Salmonella Saint Paul(Salmonella Virchow PT34)

143 (7)

Bean sprouts*

1989 Salmonella Gold-Coast 31 Cress

2010 Salmonella Bareilly >240 Bean sprouts

Source: HPA data

*Also isolated from seeds, bean sprouts, or production environmentS.ArizonaS.EnteritidisS.LancingS.LitchfieldS. MbandlakaS.VirchowPT34

Laboratory reports of Salmonella Bareilly: England & Wales 2010

Week NumberSource: Health Protection Agency

Consumer advice

LAs/trade Outbreakover 21/1

Rise in cases detected –OCTReported to ECDC

Functional Separation of RA and RM?

Yes, through the independent SACs (RA) and the FSA’s Board (RM)

Science Checklist – key science governance tool used by Board

Importance of dialogue between risk assessors and risk managers – SAC chairs attending public Board meetings

Integrated model of risk analysis that has public engagement at its heart

Openness and transparency are key to accountability and winning trust

Handling Risks: Lessons Learned

Put consumers first – be open and transparent Seek advice and challenge from independent

scientists Acknowledge uncertainty Recognise risk appetite of consumers Help consumers to make their own judgements Actively engage with stakeholders at all key stages Transparency of the contributory factors to the risk

management decisions

Thank You

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