Post on 23-Dec-2015
Why Risk Analysis?General public concern over real or imaged food-borne hazards to health
Recognition of the absence of systematic framework for assessing the risks associated with food in international trade
Inclusion of risk assessment principles in national legislation and new legislative conditions that facilitate product-liability claims
Trade agreements that require scientific validation of food safety (sanitary) measures used by national governments (SPS directs members to base national measures on risk assessment as appropriate to the circumstances)
Structure of Risk AnalysisA Scientifically Based Process
Risk Management*Risk Evaluation*Option Assessment*Option Implementation*Monitoring and Review
Risk Assessment*Hazard Identification*Hazard Characterization*Exposure Assessment*Risk Characterization
Risk Communication
Why Risk Assessment
The scientific evaluation of known or potential adverse health effects resulting from human exposure to food borne hazards
First step in risk analysis Provides very useful output
– annual occurrence of illness– annual rate of illness per 100 000 population
The Steps in Risk Assessment
1. Hazard Identification: The identification of known or potential health effects associated with a particular agent
2. Hazard Characterization: The qualitative and quantitative evaluation of the nature of the adverse effects associated with biological, chemical, and physical agents which may be present in food. For chemical agents a dose response assessment should be performed. For Biological?
The Steps in Risk Assessment
1. Exposure Assessment: The qualitative and quantitative evaluation of the degree of intake likely to occur
2. Risk Characterization: Integration of hazard identification, hazard characterization and exposure assessment into an estimation of the adverse effects likely to occur in a given population, including attendant uncertainty
Statements of Principle Relating to the Role of Food Safety Risk Assessment
1. Health and safety aspects of codex decisions and recommendations should be based on a risk assessment, as appropriate to the circumstances
2. Food safety risk assessment should be soundly based on science, decisions should take into account the uncertainty in the output of the risk assessment
Statements of Principle Relating to the Role of Food Safety Risk Assessment
3. There should be a functional separation of risk assessment and risk management, while recognizing that some interactions are essential for a pragmatic approach
4. Risk assessment should use available quantitative information to the greatest extent possible and risk characterizations should be presented in a readily understandable and useful form
General Principles of Microbiological Risk Assessment
Microbiological risk assessment should be soundly based upon science
There should be a functional separation between risk assessment and risk management
Microbiological risk assessment should be transparent
Microbiological risk assessment should clearly state the purpose of the exercise, including the form of risk estimate that will be the output
General Principles of Microbiological Risk Assessment
Microbiological risk assessment should be conducted according to structured approach that includes
*Hazard Identification*Hazard Characterization*Exposure Assessment*Risk Characterization
General Principles of Microbiological Risk Assessment
Any constraints that impact on the risk assessment such as cost, resources or time, should be identified and their possible consequences described
The risk estimate should contain a description of uncertainty and where the uncertainty arose during the risk assessment process
General Principles of Microbiological Risk Assessment
Data should be that uncertainty in the risk estimate can be determinedData and data collection systems should be, as far as possible, be of sufficient quality and precision that uncertainty in the risk estimate is minimized
Where possible risk estimates should be reassessed over time by comparison with independent human illness data
A Microbiological Risk Assessment may need re-evaluation, as new relevant information becomes available
General Principles of Microbiological Risk Assessment
A Microbiological Risk Assessment should explicitly consider
the dynamics of microbiological growth, survival, and death in foods, and the complexity of interaction between human
and agent following consumption as well as the potential for further spread
Guidelines for Application
General considerations Statement of purpose of Risk Assessment Hazard Identification Exposure assessment Hazard characterization Risk characterization Documentation Reassessment
Risk Management
The process of weighing policy alternatives to accept, minimize or reduce assessed risks and to select and implement appropriate options
Elements of Risk Management
1. Risk Evaluation Identification of a food safety problem Establishment of a risk profile Ranking of the hazard for risk assessment and risk
management priority Establishment of risk assessment policy for conduct of
risk assessment Commissioning of risk assessment Consideration of risk assessment results
Elements of Risk Management
2. Risk management option assessment Identification of available management option Selection of preferred management option, including
consideration of an appropriate safety hazard Final management decision
Elements of Risk Management
3. Implementation of management decision
4. Monitoring and review Assessment of management decision Review risk management and/or assessment necessary
General Principles of Food Safety Risk Management
1. Risk management should follow a structured approach
Risk evaluation Risk management option assessment Implementation of management decision Monitoring and review
General Principles of Food Safety Risk Management
2. Protection of human health should be the primary consideration in risk management decision
Areas of considerations Economic costs Benefits Technical feasibility Societal preference
General Principles of Food Safety Risk Management
3. Risk management decision and practices should be transparent
Identification and systematic documentation of all elements of the risk management process including decision making
4. Determination of risk assessment policy should be included as a specific component of risk management
General Principles of Food Safety Risk Management
5. Risk management should insure the scientific integrity of the risk assessment process by maintaining the functional of risk management and risk assessment
6. Risk management decisions should take into account the uncertainty in the output of the risk assessment
General Principles of Food Safety Risk Management
7. Risk management should include clear, interactive communication with consumers and other interested parties in all aspects of the process
8. Risk management should be a continuing process that takes into account all newly generated data in the evaluation of and review of risk management decisions
General Principles of Food Safety Risk Management
9. Risk management decisions should address the whole farm to table continuum including imported goods
10. Risk management decisions should be reviewed as new information become available
11. The efficacy of risk management measures has to be periodically assessed with regard to the risk management goals. These measures have to be reviewed if appropriate.
Who Does What?Codex Committees and Risk Management
Codex committees on: Food Additives and Contaminants (CCFAC) Residues of Veterinary Drugs in Food (CCRVDF) Pesticides Residue (CCPR) Food Hygiene (CCFH) General Principles (CCGP) Food Labeling (CCFL) Food Import & Export Inspection and Certification System
(CCFICS) Nutrition and Foods for Special Dietary Uses (CCNSFDU) Methods of Analysis and Sampling (CCMAS)
Who Does What?Independent Expert Bodies and Risk assessment
Joint FAO/WHO Expert Committee on Food Additives (JECFA)
Food Additives Contaminants (CCFAC) Residues of Veterinary Drugs in Food (CCRVDF)
Joint FAO/WHO Meeting on Pesticide Residues (JMPR)
Pesticides Residue (CCPR)
Main TasksIndependent Expert Bodies JECFA
Toxicological evaluation Setting specification for identity and purity
Toxicological Toxicological studies in the most sensitive species Determination of the No observed adverse effect level
(NOAEL) Adequate safety factors Estimation of the acceptable daily intake (ADI)
Main TasksIndependent Expert Bodies JECFA
Acceptable Daily Intake : An estimates of the amount of a substance in food drinking water, expressed on a body weight basis, that can be ingested daily over a lifetime without appreciable health risk
Assures no hazard to the consumer Based on risk assessment and safety factors:
extrapolation to human 10 x
difference between humans 10 x
Overall safety factor, 100 x Additional safety factors (2-10 x) if data are uncertain
Main TasksIndependent Expert Bodies JECFA
Toxicological Evaluation of Contaminants
With threshold
PTWI: Provisional Tolerable Weekly Intake No threshold
ALARA: As Low As Reasonably Achievable
Main TasksIndependent Expert Bodies JECFA
JECFA
ADI
Codex Committee onFood Additives and
Contaminants
Codex Maximum
Level
Food Additives
Main TasksIndependent Expert Bodies JECFA
JECFA
PTWI
Codex Committee onFood Additives and
Contaminants
Codex Maximum
Level
Chemical Contaminants
Main TasksIndependent Expert Bodies JECFA
JECFA
ADI & MRL
Codex Committee onResidues of Veterinary
Drugs in Foods
Codex MRLs
Veterinary Drugs
Main TasksIndependent Expert Bodies JMPR
Review of pesticide use patterns Toxicological assessment Exposure assessment Proposes MRLs, based on Good Agricultural
Practices (GAP) Estimates ADI, based on Toxicological Evaluation Compares with ADI, using MRLs and exposure
estimates
Main TasksIndependent Expert Bodies JMPR
FAO Panel of Experts on Pesticides in Food Review of pesticides use patterns (GAP), chemistry and
composition and methods of analysis Propose maximum residue limits Exposure assessment with WHO group
WHO Experts Groups on Pesticides Residues Toxicological assessment Environmental assessment Public and occupational health assessment Exposure assessment with WHO group
Main TasksIndependent Expert Bodies JMPR
JECFA
ADI & MRLs
Codex Committee onPesticide Residues
Codex MRLs
Pesticides Residues
Other Expert Bodies
For Microbiological Agents Agents (bacteria, viruses, etc) International Commission on Microbiological Specification
for Food (ICMSF)? Codex Committee on Meat Hygiene (CCMH) Codex Committee on Food Hygiene (CCFH) Recommendation in the form of codes of Hygienic practices General principles of food hygiene HACCP
Risk Assessment of Chemical Agents in Food
Hazard identification Epidemiological studies
Data derived from human clinical studies, genetic pridisposition, age and gender related susceptibility, socio economic status, nutritional status
Animal studiesAnimal data from long term (chronic) studies
Animal data from short term (acute) toxicity studies
No Observed Effect Level (NOEL)
No Observed-Adverse Effect Level (NOAEL)
Maximum Tolerated Dose (MTD)
Risk Assessment of Chemical Agents in Food
Hazard characterization Dose response extrapolation
Uncertainty in extrapolation
Hazard may change with dose or may disappear
Change in metabolism with dose
Dose-scaling (mg per kg of body weight) Genotoxic and non-genotoxic carcinogens Threshold approaches (ADI) Non-threshold approachesBan the chemical from commercial use
Establish a level of risk that is sufficiently Small (negligible)
Risk Assessment of Chemical Agents in Food
Exposure Assessment
Estimates dietary intake of food additives, residues of pesticides , and veterinary drugs and contaminants
Total diet studies Selective studies of individual foods Duplicate portion studies Direct monitoring of human tissues and body fluids Detailed food consumption data Staple foods from different regions
Risk Assessment of Chemical Agents in Food
Risk Characterization
Estimate of the likelihood of adverse effects in human populations as a consequence of the exposure
Threshold < ADI adverse effects is nationally zero Non-threshold acting agents population risk is the product of exposure and
potency Uncertainties with respect to the relevance of the experimental findings of human Uncertainties with respect to the specific human sensitivity for effects of a
chemical that can not be studied in experimental animals
Risk Assessment of Biological Agents in Food
Food will always present minimal biological risk
Biological agents of concern Bacteria Viruses Protozoa Algae
Standards and codes of practices
HACCP
Risk Assessment of Biological Agents in Food
General mechanisms in causing human illness by Biological Hazards
Produce toxins which may cause effects that range from mild symptoms of short duration to severe intoxications that can have long term or life threatening consequences (Threshold level easier to quantify)
Produce pathological responses that result from ingestion of viable organism capable of infecting host (qualitative risk assessment)
Risk Assessment of Biological Agents in Food
Hazard identification Epidemiological studies
Limitations The expense and difficulty involved in outbreak
investigations The lack of reliable or complete epidemiological
data The inability to isolate and characterize new
pathogens
Risk Assessment of Biological Agents in Food
Hazard characterization: to provide qualitative or quantitative estimates of the severity and duration of adverse effects due to the presence of pathogen in food
Limitations host susceptibility to pathogenic bacteria is highly variable attack rates from a specific pathogen vary widely virulence of a pathogenic species is highly variable pathogenicity is subject to genetic variation resultant from
frequent mutation Foods will modulate the ability of bacteria to infect and/or
otherwise affect the host
Risk Assessment of Biological Agents in Food
Exposure Assessment: an estimate of either the number of pathogenic bacteria or the level of bacterial toxin in food
Limitations Ecology of the bacterial pathogen concern Processing, packaging and storing of food Preparation steps, such as cooking, which may inactivate
bacterial agents Cultural factors relating to consumers
Risk Assessment of Biological Agents in Food
Risk characterization: depend on the considerations and information described in the hazard identification, hazard characterization and exposure assessment steps.
Qualitative estimate of the potential for adverse effects from a particular agent on a specific population
Quantitative?
Risk Analysis and Hazard Analysis
Risk Analysis: is the systematic evaluation of the risks arising from hazards in food, including risk assessment, management and communication and normally a clear statement as to whether an attribute of the food safety and to what degree it represents a food safety risk.
Hazard Analysis: is frequently based on qualitative observations and qualitative evaluation of information relating to food processing and handling operations.
HACCP: is a risk management option