Food Safety Risk Analysis

By: Gehad Abdel Nasser

Supervisor: Prof.Dr. Hussien Mansour
 Introduction
Risk analysis has become a cornerstone of modern food safety systems,
providing a structured approach to making evidence-based decisions about
potential hazards in our food supply
While the concept might sound technical, it essentially helps answer critical
questions like “How safe is our food?” and “What should we prioritize to
protect consumers?”
Egypt is one of the first countries that ratified the agreement of GATT of
the WTO
This presentation is going to the discuss the concept of Risk Analysis as the
science base for determine the MRLs of different sources of food
contaminants and the relevant national and international related
regulations
 Risk Vs Hazard
The Prime Ministerial Decree No. 412 of 2019 made the following distinction
between hazard and risk:
Hazard Risk
Any biological, chemical, Refers to the likelihood and severity of adverse
or physical agent present health effects resulting from exposure to a food
in food has the potential to hazard
cause harm to the health of It considers both the probability of occurrence and
the consumer the magnitude of the potential harm to human
health
Ex: Ex:
E coli is a hazard The probability the existence of E coli in a specific
food
 Risk Analysis
RA approach utilize the information on hazards in food to be linked
directly to data on the risk to human health, as a process which was not
considered in the past
It provides science-based approach to improve food safety decision-
making processes
RA contributes to the reduction of the incidence of foodborne disease and
continuous improvements of food safety as a structured decision-making
process,
RA includes three distinct but closely connected components:
1. Risk Management,
2. Risk Assessment and
3. Risk Communication
 Components of Risk Analysis

Risk Communication Risk Assessment Risk Management

The interactive exchange of • It deals with the • It describes the process of
information and opinions scientific process of combining the outcomes of risk
throughout the risk analysis analyzing whether assessment with other legitimate
hazard could present a factors to weigh policy
process concerning risk, risk- risk alternatives in consultation with
related factors and risk • It is based on four key all interested parties (authority,
perceptions, among risk steps: since, stalk holders and
assessors, risk managers, 1. Hazard identification consumer)
consumers, industry, the • RM considers risk assessment
2. Hazard and other factors relevant for
academic community and other
characterization the health protection of
interested parties, including the
3. Exposure assessment consumers and for the
explanation of risk assessment promotion of fair-trade
findings and the basis of risk 4. Risk characterization practices, and, if needed,
management decisions selecting appropriate prevention
and control options
 Content

• Importance of food safety risk analysis

• Food safety in developing countries
• Steps of risk analysis
• Steps of each component of risk analysis
• Global risk analysis consensus
• Risk analysis capacity in developed and developing countries
• WTO requirements and their relation to risk analysis
• Case study
• References
 Importance of Food Safety Risk Analysis
• Risk analysis is used to assess the risks to human health and safety, to
identify, implement appropriate measures to control the risks and lastly to
communicate with stakeholders about the risks and determine the necessary
measures
Main Benefits:
1. Support and improve the development of Food Safety criteria
2. Address food safety issues that result from emerging hazards or
breakdowns in food control systems
3. Risk assessment provides food safety regulators with the information and
evidence they need for effective decision-making
4. Contributing to better food safety outcomes and improvements in public
health
 Food Safety in Developing Countries
Food safety in developing countries consider a critical global public health
issue, as foodborne diseases continue to cause significant human suffering
and economic loss
In response to the ineffective multiple control food safety authorities casing
significant challenge to the safety of food chain, the National Food Safety
Authority (NFSA) was established under Law No. 1 of 2017 as an attempt to
unify the authority in one component authority
The law obliged NFSA to set the necessary procedures for risk analysis,
assessment, usage, management, communication and awareness including
setting inspection priorities, while taking into account the methods of risk
assessment, analysis and management followed by the relevant international
organizations
 Steps of Risk Analysis
• According to FAO, the risk analysis process normally begins with a risk
management step
• But, According to Alie de Boer*, RA is the first step in a process known as ‘risk
analysis’: the systematic Approach upon which food policy and related decisions
should be based, whereas scientific questions are addressed in risk assessment, the
second component of risk analysis is focused on weighing policy alternatives to
appropriately deal with the risk that needs to be dealt with in policy The third
constituent of risk analysis is risk communication
*Applied food science, (Food Claims Centre Venlo, Faculty of Science and
Engineering, Maastricht University, Nassaustraat 36, 5911 BV Venlo, the Netherlands)
 Steps of Risk Analysis
The main thing is the three components
are essential, complementary each other
in an overall discipline structure
• Although the figure shows them as
separate entities, in reality they are
highly integrated
• During a typical food safety risk
analysis, almost constant interactions
occur between risk managers and risk
assessors within an environment
characterized by risk communication
• Risk analysis is most effective when all
three components are successfully
integrated by the risk managers
directing the process
Steps of Each Component of Risk Analysis
Risk Management Risk Assessment Risk Communication
Phase 1: Preliminary Risk Management 1. Scientific approaches for 1. Key
Activities assessing risks communication
2. Responsibilities of risk elements of food
Step 1: Identify the problem managers in commissioning & safety risk analysis
Step 2: Develop the risk profile administering a risk assessment 2. Some practical
Step 3: Establish risk management goals 3. General characteristics of risk aspects of risk
Step 4: Decide whether a risk assessment is assessment communication
needed 4. Risk assessment methodology:
Step 5: Establish a risk assessment policy • Hazard identification
Step 6: Commission the risk assessment • Hazard characterization
Step 7: Consider the results of the risk • Exposure assessment
assessment
Step 8: Rank risks • Risk characterization
Phase 2: Identification and Selection of Risk 5. Integrating risk assessment and
Phase 3: Implementation economic assessment
Phase 4: Monitoring and review
 Global Risk Analysis in
Application of Food Safety Risk Analysis differs in:

Developing
Developed
Countries
Countries
 Food Safety Risk Analysis Capacity in Developed Countries
In US
1. FDA: conducts risk assessments and safety assessments. These assessments use a scientific
approach to understand and to quantify specific food safety risks
For risk assessments, FDA develops mathematical models and other tools that simulate a
microbial or chemical food safety problem, integrating the many factors that contribute to it
2. FSIS:The Food Safety and Inspection Service (FSIS) has issued a directive on its official
website detailing how to conduct a comprehensive assessment of a food safety system in a
specific establishment within seven production days
3. APHIS: The Animal and Plant Health Inspection Service (APHIS), a division of the U.S.
Department of Agriculture (USDA), plays a pivotal role in safeguarding U.S. agriculture and
natural resources by conducting comprehensive pest risk assessments (PRAs)
These assessments evaluate the potential risks associated with importing plant and animal
products, ensuring that only safe and healthy commodities enter the United States
4. EPA: The mission of EPA is to protect human health and the environment EPA works to
ensure that: Americans have clean air, land and water, reduce environmental risks are based
on the best available scientific information
 Food Safety Risk Analysis Capacity in Developed Countries
In EU
EFSA has regular contacts with risk managers and decision-makers in the
EU food safety system: European Commission, European Parliament and
EU Member States
They are the main users of EFSA's scientific advice
EFSA also has links with other EU agencies and bodies carrying out scientific
assessments, research and data collection in areas related to EFSA’s work,
e.g. chemical safety, microbiological safety, feed, environment, human and
animal health
 Food Safety Risk Analysis Capacity in Developing Countries
Case of Egypt

In Egypt Risk Analysis has not yet been effectively implemented in Egypt
The process stalled at the legislative stage, and no practical mechanisms or
frameworks have been established to apply food risk analysis on the ground
Egypt continues to face many of the common challenges encountered by
developing countries in this field, including the absence of trained risk
assessment teams and limited awareness or understanding of risk analysis
principles among relevant stakeholders
 WTO Requirements and their Relation to Risk Analysis
The World Trade Organization (WTO) is the official international
organization dealing with the global rules of trade
Its main goal is to improve the welfare of people around the world by
ensuring that trade flows as smoothly, predictably and freely that based on
science
According to the Agreement on the Application of Sanitary and
Phytosanitary Measures (SPS Agreement), which came into effect in 1994 with
the official establishment of the World Trade Organization (WTO), with the
purpose of this agreement is to ensure that sanitary measures (such as food
inspections and plant quarantine procedures) are not used as a disguised means to
restrict international trade and must based on science
 WTO Requirements and Their Relation to Risk Analysis
The SPS Agreement does not require developing countries to conduct their own risk
assessments from scratch

Instead, it grants them the right to rely on assessments carried out by other countries or
international organizations such as:
 Codex Alimentarius (for food safety)

 OIE – World Organization for Animal Health (for animal health)

 IPPC – International Plant Protection Convention (for plant health)

This is clearly reflected in the wording of Article 5.1 of the SPS Agreement:

•"Members shall ensure that their sanitary or phytosanitary measures are based on an
assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or
health, taking into account risk assessment techniques developed by the relevant international
Furthermore, Article 10.1 states:

"In the preparation and application of sanitary or phytosanitary measures,

Members shall take account of the special needs of developing country
Members, and in particular of the least-developed country Members"

And Article 10.4 states:

"Members should encourage and facilitate the active participation of

developing country Members in the relevant international organizations"

These provisions emphasize that developing countries are allowed to use risk
assessments carried out by external parties if suitable to their national
context Moreover, the WTO and other international organizations are
encouraged to provide technical assistance to help developing countries
 Applications of Risk Analysis

Risk Assessment
• On Large Scale:
• Food Safety Programs In
Competent Authorities Risk Management
• Inspection Results Risk Communication • On Large Scale:
• Expert Committees in • External Stakeholders Competent
Government Agencies • Consumer Protection Authorities
• Epidemic Problem • External Experts Administrations
• All Parts Related to • On Small Scale:
• On Small Scale: Food Safety Issue • Food Business
• Food Safety Programs In Operator
Food Facilities • Academic Affairs
• Academic Parties Officer
 Case Study of Listeria Monocytogenes in Ready-to-Eat Foods

Listeria monocytogenes is a food-borne bacterial pathogen that can cause listeriosis,

a severe disease that can result in septiceamia, meningitis and spontaneous abortion
Given the importance of this disease, the “USA Healthy People 2010” goals for
national health promotion and disease prevention called on federal food safety
agencies to reduce food-borne listeriosis by 50 percent by the end of the year 2005
While increased government and industry attention to general aspects of L.
monocytogenes control would result in some decrease in incidence, specific risk
management actions were needed
 Risk Management
Phase 1: Preliminary Risk Management Activities
Step 1: Identify the problem
Step 2: Develop the risk profile
Step 3: Establish risk management goals
Step 4: Decide whether a risk assessment is needed
Step 5: Establish a risk assessment policy
Step 6: Commission the risk assessment
Step 7: Consider the results of the risk assessment
Step 8: Rank risks
Phase 2: Identification and Selection of Risk
Phase 3: Implementation
Phase 4: Monitoring and review
 Risk Assessment
Hazard Characterization:
Focused on severe illness/death in three groups: prenatal/perinatal, elderly, and
intermediate age
Dose-response models were built using contamination, growth, and
epidemiological data
Mild gastroenteritis was excluded
Exposure Assessment:
Based on contamination levels, growth before consumption, serving size, and
yearly consumption
Data showed most servings had very low contamination, but a few had
extremely high levels
Risk Characterization:
Illness estimates were calculated by food category and population group
High risk is linked to foods that allow L. monocytogenes to grow to high levels
Most cases stemmed from a small number of highly contaminated servings
 Risk Communication
• Risk communication was incorporated at various points throughout the risk analysis as
indicated in the above discussion
• Different approaches were used to communicate with external stakeholders about the
nature and effects of the specific food safety risks faced
• These includes:
o public meetings and calls for scientific data and information before the risk assessment
was commissioned,
o public meetings to seek feedback from interested groups (including the scientific
community)
o and peer review an initial draft risk assessment, and complementary activities to enhance
knowledge among consumers and health care providers about the prevention of listeriosis
 References
 Food and Agriculture Organization of the United Nations (FAO), & World Health Organization
(WHO). (2006). Food safety risk analysis: A guide for national food safety authorities. Rome, Italy:
FAO and WHO.

 de Boer, A. (n.d.). Risk analysis for foods: This is what you need to know about risk analysis in EU
food law. Food Claims Centre Venlo, Faculty of Science and Engineering, Maastricht University.
 Food and Agriculture Organization of the United Nations (FAO), & World Health Organization
(WHO). (2005). Risk analysis for foods: This is what you need to know about risk analysis in EU
food law. Rome, Italy: FAO and WHO. Retrieved from http://www.fao.org/es/ESN/index_en.stm
 European Food Safety Authority (EFSA). Hazard vs. risk retrieved from
https://www.efsa.europa.eu/en/campaigns/hazard-vs-risk#:~:text=A%20Hazard%20is%20something
%20that,of%20a%20hazard%20causing%20harm
.

 https://www.food-safety.com/articles/4471-anticipating-food-safety-risks