Why Risk Analysis? General public concern over real or imaged food- borne hazards to health ...

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


Microbiological risk assessment should be conducted according to structured approach that includes

*Hazard Identification*Hazard Characterization*Exposure Assessment*Risk Characterization


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


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


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


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


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


2. Protection of human health should be the primary consideration in risk management decision

Areas of considerations Economic costs Benefits Technical feasibility Societal preference


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


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


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


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)


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


Toxicological Evaluation of Contaminants

With threshold

PTWI: Provisional Tolerable Weekly Intake No threshold

ALARA: As Low As Reasonably Achievable


JECFA

ADI

Codex Committee onFood Additives and

Contaminants

Codex Maximum

Level

Food Additives


JECFA

PTWI

Codex Committee onFood Additives and

Contaminants

Codex Maximum

Level

Chemical Contaminants


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


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


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)


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)


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 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


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)


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


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


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 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

Why Risk Analysis? General public concern over real or imaged food- borne hazards to health ...

Documents

Transcript of Why Risk Analysis? General public concern over real or imaged food- borne hazards to health ...