the concept and use of risk analysis in food safety jeronimas maskeliunas md, phd secretariat, codex...
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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!
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