The Concept and Use of Risk Analysis in Food

Safety

Jeronimas Maskeliunas MD, PhD

Secretariat, Codex Alimentarius Commission

Food and Nutrition Division, FAO of the United Nations

Almaty, 13-18 October2002

The Concept and Use of Risk Analysis in Food Safety

1. Concept and Use of Risk Analysis in Codex 1991 - 2002 2. Conclusions

Risk analysis - new concept?

Risk and Codex

Risk Analysis-New Concept?

Risk analysis existed for over a century and was widely used in such diverse areas as: insurance investment engineering

Risk Analysis

Risk analysis was not designed to provide a decision

Instead it was tool to support decision - making

FACT

In most countries the decision concerning whether a risk was acceptable and what would be done to reduce or eliminate risk was and is taken at a political level

FACT

Risk is composed of two main elements:

the probability or likelihood of an adverse effect occuring

magnitude of the consequences

Classical example:

In walking across the street the probability of being hit by:

a pedestrian; bicycle or carcould be the same however consequences would be very different

FACT

Everyone faces potential hazards and risks every day

Hazards and risks are natural part of life

Why do we need to do risk assessment?

Risk and Codex

Science and Risk in Codex

All Codex Committees should continue to base their evaluations on suitable scientific principles

The CAC and its relevant Committees …. should make explicit the methods they have used to assess riskJoint FAO/WHO Conference on Food

Standards, Chemicals in Food and Food Trade, Rome, 1991

Risk Analysis and Codex

1991 CAC accepted the Conference Recommendation

Risk Analysis and Codex

1993

CAC approved the use of risk analysis in Codex work

Risk Analysis and Codex

The decisions of the Codex in 1991 and 1993 to base its work on risk analysis predated the WTO SPS Agreement of 1995

The SPS AgreementArticle 5.1

Members shall ensure that their sanitary and phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life and health, taking into account risk assessment techniques developed by the relevant international organizations

The SPS AgreementArticle 5.2

In the assessment of risks, Members shall take into account available scientific evidence; relevant process and production methods; relevant inspection, sampling and testing methods; prevalence of specific diseases or pests; existence of pest- or disease-free areas; relevant ecological conditions; and quarantine or other treatment.

FACT

Countries may introduce or maintain different standards (measures), based on scientific justification or use a higher level of protection (Article 2.3)

The scientific justification must be based on a risk assessment(Article 2.3 and Article 5)

Note

Food safety measures that conform to the standards elaborated by the Codex Alimentarius Commission are presumed to be consistent with the WTO’s SPS Agreement

This means that no further risk assessment is required: Codex has already provided it

Codex Alimentarius Commission and Risk Analysis

Statements of Principle Concerning the Role of Science in the Codex Decision Making Process and the Extent to Which Other Factors Are Taken Into Account

Statements of Principle Relating to the Role of Food Safety Risk Assessment

Definitions of Risk Analysis Terms Related to Food Safety

Definitions of Risk Analysis TermsRelated to Food Safety

* Hazard* Risk* Risk Analysis* Risk Assessment* Hazard Identification* Hazard

Characterization

* Dose-Response Assessment

* Exposure Assessment* Risk Characterization* Risk Management* Risk Communication

Concept of Risk Analysis

Risk Analysis: A process consisting of three components: risk assessment, risk management and risk communication

Concept of Risk Analysis

Risk Assessment: A scientifically based process consisting of the following steps:(i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization

Principles and Guidelines for the Conduct of MRA - 1999

Definitions of relevant terminology

General principles sound science, structured

approach, interaction with RM, statement of purpose, transparency, constraints, uncertainty, reality check, review

Guidelines for application

Hazard Identification

Physical Chemical Biological

Hazards

Physical: stones, metal pieces in flour or

bread

Hazards

Biological Pathogenic bacteria (>80% of outbreaks)Moulds (Mycotoxins)Viruses (Hepatitis A) Parasites (Trichinella; Toxoplasma)

Hazards

ChemicalNatural: numerous toxins (mycotoxins, Phycotoxins; Saponins; Vicine in fava beans; cyanogenic glycosides; tannins; Gossypol; etc…)Industrial: PCBs, Dioxins; Heavy metalsAgricultural: Pesticides; Fertilizers

Hazards

Chemical (cont.)Veterinary: animal drug residues Food additives: Colours, flavours, preservatives, emulsifiers, thickening agents, etc..Processing aids: (extraction solvents)Packaging materials: plastic monomers

Hazard Characterization

Qualify and/or quantify the nature and adverse health effects associated with hazards in food.

For chemical hazards a dose-response assessment should be performed

Note that:

Results of hazard chacterization (ADI, PTWI, etc) are valid for all populations

Diet variations and other population variations are built into the safety factors

Exposure Assessment

Quantitative or qualitative evaluation of the likely intake of hazards via food, water as well as exposures from other sources, if relevant

Exposure Assessment

Limitations at the international level

Certain data available only at the national level

Data more accurately reflecting the reality are available at the national level

Characterize risk

In order to determine the severity of potential health effects - the results of the exposure assessment should be compared with the toxicological endpoints recommended by JEXFA/JMPR

Risk Characterization

Use ADIs, PTDIs/PTWIs, Acute RfDs recommended by JECFA/JMPR or other international/regional bodies

Use proposed evaluations by JECFA/JMPR

Regional cooperation

Microbiological hazards vs chemical hazards

Microbiological hazardsMicrobiological hazardspathogen-commodity

combinationsingle exposureindependent non-

cumulative eventvariable responsenumbers can change up

or downdynamic and adaptable -

different characteristics

Chemical hazardsChemical hazardsone chemical - many

foodsmultiple exposurescumulative effecttoxic levels stable or

decrease during storage

no dramatic change in toxicity

Definitions of Risk Analysis TermsRelated to Food Safety (continued)

Risk Management: The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options

Definitions of Risk Analysis TermsRelated to Food Safety (continued)

Risk Communication: The interactive exchange of information and opinions throughout the risk analysis process concerning hazards and risks, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions

Principles of risk analysis

soundly based on science, consistent, open and transparent

fully and systematically documented in a transparent manner

functional separation of risk assessment and risk management

situations of developing countries should be specifically identified and taken into account

Principles of risk analysis

precaution is an essential element of risk analysis

when there is evidence that a risk to human health exists but scientific data are insufficient or incomplete, Codex does not proceed to elaborate a standard but considers elaborating a related text, such as a code of practice, provided that such a text would be supported by the available scientific evidence

Hazard Analysis vs Risk Analysis

Hazard Analysis deals with hazards that you can

measure in foodtypically is quantitative carried out at company levelprocessing plant/commodity

specific

Risk Analysis

typically is qualitative carried out by governments

and/or regulatory institutions focuses on the control of an

industry-wide public health problem (e.g. listeriosis in ready-to-eat foods)

Risk Analysis

outcome is quantitative or qualitative estimate of the likelihood of and adverse consequence due to exposure to a hazard to one or more populations, the development of one or more options to manage risk, and the development of recommendations to communicate the management of the risk to consumer

Risk analysis should

Identify hazards Characterize risks Recognize uncertainty Summarize conclusions Recommend options Document the basis for decisions

CAC 1999

Programmes that contribute to risk analysis should have high priority

Relevant Codex committees should continue to develop and apply risk analysis principles and methodologies appropriate to their specific mandates

Risk management should take into account the economic consequences and the feasibility of risk management options in developing countries

Risk Analysis and Codex

December 1999 onwards FAO/WHO Programme of activities on microbiological risk assessment convened in response to request from CAC / CCFH

FAO/WHO Risk assessment EC

Salmonella spp in broiler chickens and eggs

Listeria monocytogenes in ready to eat foods

Campylobacter spp. in broiler chickens

Vibrio spp. in seafood

Outputs

Risk assessment monographsInterpretative summariesGuidelines documents

hazard characterization exposure assessmentrisk characterization

Where to put intellectual and financial resources?

Risk and Codex

Risk assessment

Principles and methodology of risk assessment are equally valid for all countries

No need to put resources there

Surveillance infrastructure weak or non-existent;

Different reporting systems; Information kept secret

sometimes; Lack of resources and

programmes for this purpose;

Constraints in data collection

Data availability - current limitations

data not collected or generatedunpublished and not available by

other meansconfidentialnot available in a format useful

for risk assessment

Data availability - current limitations

insufficient information for example on how it was generated

not comparable due to use of different methodologies in collecting or generating data

not aware of all the data sources

Sources of data

National surveillance dataEpidemiological surveysIndustrial surveys Research publicationsUnpublished research workGovernment reportsFood analyses data - import /

export, food control sampling

Техническая помощь FAO странам-членам :

FAO Technical Cooperation Programme

Regional and National Seminars, Workshops on Risk Analysis

Projects to generate the necessary data

ConclusionsConclusions

Risk assessment

Conclusions

The introduction of risk analysis as a discipline in standardization has opened new possibilities for international harmonization

Conclusions

The concept can be extended further to establish conditions for determining the equivalence of measures or systems designed to address risk

Conclusions

Countries can compare their standards, codes and other measures to determine if they are equivalent to internationally accepted standards or the standards of their trading partners

Conclusions

Scientific analysis of potential hazards has proved to be a firm basis for decision-making in the management of food safety risks

Scientific evidence is not sufficient in itself for the establishment of risk management measures

Conclusions

other legitimate factors need to be taken into account, but they need to be well

documented should not affect the scientific

process are not an alternative to the

scientific process

Conclusions

Use scientific data provided by JECFA, JMPR, FAO/WHO Expert Consultations

Adopt and/or use Codex risk based standards, MRLs, codes of practice, guidelines etc - save resources

Prioritise areas of work and available funds

Contact !

Joint FAO/WHO Food Standards Programme

Food and Nutrition Division, FAOViale delle Terme di Caracalla00100 Rome, ItalyFax +39 (06) 5705.4593E-mail : codex@fao.org

Visit Our Website

Http://www.codexalimentarius.net

JECFA Related Information http://www.who.int/pcs/JECFA/jecfa.htm

JMPR Related Information http://www.who.int/pcs/JMPR/JMPR.htm

Expert Consultation Reports http://www.fao.org/WAICENT/FAOINFO/

ECONOMIC/ESN/expertfq.htm

Thank you very much for your kind attention and wish all

success!