DR.D.KANUNGO ADDITIONAL DIRECTOR GENERAL(Rtd.) Ministry of Health and FW & Chairperson Scientific Panel on Pesticide and Antibiotic Residues FSSAI
UNDERSTANDING GLOBAL PRACTICES IN RISK ANALYSIS OF CHEMICAL CONTAMINANTS
Geeta ,Chapter-17 Verse8-10 •
The Food which is stale, tasteless, putrid, decomposed, foul and impure as well as the remnants of others is dear to one in nescience. Srimad Bhagwat Geeta Chapter 17 Verse-10
• Over 200 diseases are caused by unsafe food containing harmful bacteria, parasites, viruses, chemical substances. • 2 million deaths occur every year from contaminated food or drinking water.(Estimated)
The Food and Agriculture Organization of the United Nations (FAO) and World Health Organization (WHO) have a long history of collaboration in the Safety Evaluation of Chemicals in food . This activity began in 1956, when the first meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) was convened by the two organizations, and was strengthened in the early 1960s
Codex Alimentarius Commission (CAC) • Organization of FAO/WHO- Since 1962 • Responsible for developing standards, guidelines • Recommendations on the quality and safety of food to protect the health of consumers • Ensure fair practices in food trade
Codex Alimentarius Commission (CAC)- Executive Committee General Subject Committees Commodity Committees • CCCPL Codex Committee on • Cereals, Pulses and CCCF Codex Committee on Contaminants in Foods Legumes • CCFA Codex Committee on Food Additives • CCFFV Codex Committee on • CCFH Codex Committee on Food Hygiene Fresh Fruits and • CCFICS Codex Committee on Food Import and Export Inspection and Certification Systems Vegetables • CCFL Codex Committee on Food Labelling • CCFO Codex Committee on Fats • CCGP Codex Committee on General Principles and Oils • CCMAS Codex Committee on Methods of Analysis • and Sampling CCPFV Codex Committee on • CCNFSDU Codex Committee on Nutrition and Foods Processed Fruits and for Special Dietary Uses Vegetables • CCPR Codex Committee on Pesticide Residues • CCS Codex Committee on Sugars • CCRVDF Codex Committee on Residues of Veterinary Drugs in Foods • CCSCH Codex Committee on Spices and Culinary Herbs
Scientific basis for Codex work • Codex committees - apply Risk Analysis • Independent scientific advice by expert bodies • JECFA - Joint FAO/WHO Expert Committee on Food Additives • JMPR - Joint FAO/WHO Meeting on Pesticide Residues • JEMRA - Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment
Contaminants in the diet ❖ Environmental pollutants, such as -heavy metals ,industrial chemicals, ❖ Mycotoxins, ❖ Migrants from packaging materials ❖ Other substances not authorized for use in food. ❖ EMRL Food contaminants are generally unavoidable
CODEX EVALUATES THE CONTAMINANTS THROUGH THE PROCESS OF RISK ANALYSIS
Selection of compounds on the agenda FAO /WHO MEMBER PRIORITY LIST CCCF STATES Earlier JECFA SECRETARIATE May add on its own meetings of JECFA. AGENDA
How do we characterize contaminants in food • The data on total diet • Concentrations of contaminants in foods • Details on sampling plans • Analytical methods used to generate the data.-LOQ • Substances consumed in large amounts-May have impurity of contaminants
Risk analysis Risk analysis has been defined by CAC as “ a process consisting of three components: risk assessment, risk management and risk communication”, which are themselves defined . (FAO/WHO, 2008):
RISK ANALYSIS Risk Assessment •Hazard identification •Hazard characterization •Exposure assessment •Risk characterization Risk Management Risk Communication •Risk evaluation •Interactive exchange of information and opinions •Option assessment concerning risks •Option implementation •Monitoring and review
What is risk assessment? • Uses data, etc. to estimate the probability that harm will occur as a result of exposure to specific hazards. – IDENTIFY REAL OR POTENTIAL HAZARD – DETERMINE PROBABILITY OF IT HAPPENING – ASSESS SEVERITY ON HEALTH, ENVIRONMENT, ECONOMY, OR SOCIAL IMPACT
Role of Risk Assessment in Risk Analysis for Food Chemicals • Risk assessment -the central scientific component of risk analysis • Make decisions to protect health in the face of scientific uncertainty. • Characterizing the potential hazards and the associated risks to life and health resulting from exposure of humans to chemicals present in food over a specified period.
What is risk? What is Hazard?
Hazard Vs Risk ● Hazard : Inherent property of an agent or situation having the potential to cause adverse effects when an organism, system or (sub)population is exposed to that agent. ● Risk : The probability of an adverse effect in an organism, system or (sub)population caused under specified circumstances by exposure to an agent. (WHO/IPCS,2004)
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RISK Hazard ASSESSMENT identification Hazard characterization Exposure assessment Risk characterization
Four-step process for human health risk assessments: Step 1 - Hazard Identification Examines whether a substance has the potential to cause harm to humans and/or ecological systems, and if so, under what circumstances. Step 2 - Dose Response Assessment Examines the numerical relationship between exposure and effects. .
Four-step process for human health risk assessments Step 3 - Exposure Assessment Examines what is known about the frequency, timing, and levels of contact with a substance. Step 4 - Risk Characterization Examines how well the data support conclusions about the nature and extent of the risk from exposure to chemicals.
Hazard Identification Hazard Identification Hazard characterization Is there a problem? Exposure How do assessment you know? Risk characterization
Hazard identification Purpose • To evaluate the weight of evidence for adverse health effects, based on assessment of all available data on toxicity and mode of action. Designed to primarily address two questions : • 1) Nature of any health hazard to humans that an agent may pose and • 2) Circumstances under which an identified hazard may be expressed.
Hazard identification is based on analyses of a variety of data • Toxicological studies • 1) in vitro studies, using cultured organisms or cells or tissue preparations from laboratory animals or humans; - reduced, refined or replaced But No Guidance value • 2) in vivo studies in laboratory animals or humans. • OECD Guideline • Data generated -GLP
HAZARD IDENTIFICATION Animal Studies • Mouse • Rat • Rabbit • Guineapigs
DATA ON TOXICITY • Acute Toxicity Studies • Short term toxicity Studies • Metabolism in Animals (Pharmacodynamics and toxicokinetics) • Genotoxicity • Immunotoxicity
DATA ON TOXICITY(cont) • Carcinogenicity • Effect on reproduction • Developmental Toxicity • Neurotoxicity • Information on Effect on Human being
• The extent of toxicological testing required depends on the nature and use of the substance under consideration. • Not all of the tests necessarily in order to reach a conclusion on the risk assessment for a particular substance. • Tiered testing approaches are used in which screening tests or a limited number of standard toxicity studies are conducted, which may be sufficient for risk assessment or may trigger necessary further investigations.
Interpretation of findings • Critical evaluation of study designs and their findings and interpretation of the results are the most important steps in risk assessment • Assessment of many toxicological end-points, • Weight of evidence approach • Evidence of dose – response relationships • An overall assessment of the available data
Dose – response assessment • Dose – response assessment is a major part of the hazard characterization within the risk assessment paradigm. • Dose – response assessment is used to develop risk assessment advice and to derive health- based guidance values.
Dose – response modelling have six basic steps. • Data selection, • Model selection, • Statistical linkage • Parameter estimation • Implementation • Evaluation of the results of the analysis.
DERIVATION OF POD • NOAEL • LOAEL • BMDL
Dose-response Assessment and Endpoint Selection : Definitions Endpoint : Toxic Effect upon which the risk assessment is based Lowest Observed Adverse Effect Level (LOAEL): Lowest dose from a study at which adverse toxic effects were observed No Observed Adverse Effects Level (NOAEL): The dose below the LOAEL at which no adverse toxic effects are observed Point of Departure (POD): Any dose level used to quantify risk (generic)
NOAEL / LOAEL Dose Spacing Will always NOAEL / LOAEL dose lead to a spacing usually ranges conservative between 2X and 10X. (protective) True NOAEL will be hazard somewhere between the estimate NOAEL and LOAEL
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