After completion of this course students are expected to be able to:
- contribute as a specialist to the solution of complex problems;
- make use of risk assessment in formulating risk management options;
- propose risk management options taking into account scientific, societal, economic, lega...
Table of Contents
Introduction to food safety management............................................................................... 2
Who does what? ............................................................................................................................2
Low dose cancer risk extrapolation ........................................................................................ 3
Chemical safety of drinking water........................................................................................ 11
Geochemical characteristics of the soil ......................................................................................... 11
Environmental contamination of soil and surface water. ............................................................... 12
Argumentation skills ........................................................................................................... 21
Essay ........................................................................................................................................... 22
E-module ............................................................................................................................. 22
HACCP ......................................................................................................................................... 22
Pre-requisites .....................................................................................................................................................24
12 steps and the seven principles ......................................................................................................................24
Food fraud........................................................................................................................... 29
Technical opportunities................................................................................................................ 31
Opportunities in time and place ................................................................................................... 32
Motivated offenders .................................................................................................................... 32
Cultural behavioral ...................................................................................................................... 32
Controls ....................................................................................................................................... 33
Managerial control measures ....................................................................................................... 36
Incident management ......................................................................................................... 36
Liability ............................................................................................................................... 44
Risk assessment examples ................................................................................................... 47
Consumer perspective on food risk management ................................................................. 47
Consumer perspective on food risk management (lecture) ................................................... 51
Social amplification theory ........................................................................................................... 51
Key factors of consumer risk management perception .................................................................. 51
,Introduction to food safety management
• Short term: consumer complaints, incidents, crisis
• Intermediate term: HACCP, audits, certification, regulation
• Long term: risk management, lobbying
Incidents
• What to decide? (stop production, recall)
• How to communicate? (media, consumers, authorities)
→ for these situation normally an emergency protocol is prepared
• What to do in what crisis?
• Who to inform? Emergency numbers?
• Who is responsible?
→ be prepared and be flexible
Intermediate term: proactivity
How to prevent problems, incidents and compliance to law.
GMP, HACCP, audits, certification
Long term: risk management
The process, distinct from risk assessment, of weighing policy alternatives, in consultation with
all interested parties, considering risk assessment and other factors.
… and if needed selecting appropriate prevention and control.
Who does what?
Risk assessment: Scientist!
Risk management: Government, companies, international trade
Risk communication: consumers, scientists, risk managers, companies
Risk communication importance of working and formulation!
Could cause vs causes
Where is the information from?
How was the information obtained?
Risk assessment
Hazard identification, hazard characterization, exposure assessment, risk characterization
Risk= probability * severity of the effect.
,Low dose cancer risk extrapolation
You need methods to set priorities.
There are two types of food chemicals that may occur in the food chain. That may cause risk to
human health and first these are compounds that we can easily avoid. These are compounds
that we add to the food additives. But there is also a big category of compounds that nobody
adds intentionally into the food but they are there because they are part of the environment.
They are contaminants in the environment for example those in the grass that once the cow
eats gets into the milk and then into diet of humans. Unavoidable compounds can cause cancer
by genotoxic mode of action and in the past the risk management of these compounds was
very easy and they manage it with ALARA just telling them they make the level of compound of
concern ALARA (as low as reasonably achievable) and it worked well for many years until the
previous century however in modern times the whole situation changed because as you may be
aware, all fields of sites development also de field of analytical chemistry and that means that
in modern times also in the modern food chain they can detect all kind of chemicals at very high
sensitivity and low detection limits and they found all kind of chemicals all over the food chain
so if you analyze baby food with high sensitivity you will find compounds of concern maybe
genotoxic carcinogens and because is estimated that based on the development of analytical
methods every four years the detection limits are reduced 10 folds we can measure 5 more in
the samples and all kind of chemicals because we have much lower detection limits. In addition
the methods also developed to analyze more samples in the same amount of time so that also
adds to the fact that you detect far more in the food chain. You can analyze 10 samples or a
hundred. You have ten times more chances to find something. We have an increasing number
of samples in the food chain, where we do detect low amounts of genotoxic carcinogens and if
you then apply ALARA to all these chemicals then your industry manager will say yes, this is a
nice risk management but you can tell me on which 10 hundred I need to start because I cannot
do everything. In modern risk management ALARA is not longer adequate because you have to
make choices so you need a method to say which of the chemical that you find in your food
samples requires the highest priority and where you should focus your risk management so this
is very important “How risk management changed over the last decades” and this also means
that you need tools to make this kind of choices and to set priorities and one very important
tool there is the tool that we will discuss in this hour.
Especially for genotoxic carcinogenic compounds: You need methods to set priorities and that
means that you have methods to judge the risk for human health. Is it a management priority?
The level that I detect by by-product. And a set ALARA was there the risk management of this
problems but its not longer valid because you need to set priorities and we have three other
methods that are actually used in the world to set this priorities. The first one is the threshold
of toxicological concern and it is not very helpful because is a very low value and most
genotoxic will exceed that threshold and then we have a method called the virtual safe dose
(VSD) and the margin of exposure (MOE) and this last one is the major risk management tool
, applied in the world. Especially in Europe,in the USA they still use the VSD to see which risks are
having the highest priority and why you should put the risk management. Now we will look at
this three in some detail and I will try to explain why some are more useful and used preferably
over the other ones.
First the virtual safe dose: quantitative risk assessment
It has an advantage that it has a quantitative risk assessment. It will tell you I have a carcinogen
which is genotoxic in my food at certain level and if I eat a certain amount of that food how
high is my cancer risk? So is really quantifying your risk. In principle that is very nice and the
way. You look for the data you have of the chemical and this is for animal experiment. What
you wanna know is a dose level and that is called the virtual safe dose and that is the dose that
will cause one in a million cancer risk upon life time exposure. One out of million.
Why experimentally you cannot describe the virtual safe dose? Because you would need
1000000 (million) animals to test.
Example: Chlooramphenicol in shrimp
It is antiobiotic
Fingers in this chemicals to avoid microbiological infection while picking up the shrimps.
Threshold of Toxicological Concern
(TTC)
This value defines certain level of
exposure of which experts say based
on the data that we have on all kind of
chemicals we considered as long as
exposure is below its level of no
concern. We have a threshold for
toxicological concern (TTC) for
genotoxic carcinogenic compounds
and it is established as follow: People
have collected the tumor data for a
large number of chemicals and from
that tumor data they have collected dose levels that give 50% of tumor incident and the
experimental range and then they made a curve where they made a plot with how many of the
chemicals had an effective dose 50% and a certain value so here you see the dose level on this
axis (actually the negative of the algorithm so high doses are here and low doses are here) Few
compounds have such a high TD50 they are not so high potency carcinogens so few here with
low concentration already give 50% tumors and most chemicals are in these region with the
concentration that gives 50% tumor incident. Now from this distribution what they did is what I
just explained you. They did linear extrapolation to predict the virtual safe dose so the assume
for all of them. This is the dose level that gives 50% tumor incidence at zero you have zero you
draw a line and just saw at what level I then have in a million to tumor risk and a set here a
lower levels of this distribution. From this experimental data. This extrapolating to a virtual safe
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