0011 A risk assessment analyzes the state of affairs at one
point in time, utilizing the best available information
at that time. As situations change, and significant new
information becomes available, a reassessment or
update should be carried out. A risk assessment can
be thought of as a live and continuing process.
Risk Assessment of Chemical Hazards
0012 In hazard identification, information as to what con-
stitutes a hazard is frequently limited. The ‘weight-of-
evidence’ approach is usually adopted, relying on a
combination of relevant sources of information, in-
cluding epidemiological studies, animal toxicological
studies, in-vitro assays, and quantitative structure–
activity relationships. In the majority of cases,
clinical, and epidemiological data are unavailable or
inadequate, and much reliance is placed on animal
studies. These would include long-term chronic stud-
ies as well as short-term acute toxicity studies. They
are designed to identify the range of toxicological
effects, such as cancer, reproductive/developmental
effects, neurotoxic effects, and immunotoxic effects.
They can also provide information on the relevance of
these effects for human risks through characterizing
the mechanism of action. In-vitro studies may pro-
vide information on genotoxicity, pharmacokinetics,
and pharmacodynamics.
0013 One particular issue with animal toxicological
studies is the need to use a relatively high dosage in
order to identify the toxicological effects. However,
realistic contamination levels in food are typically
orders of magnitudes lower, and the significance of
the identified health effects is uncertain. This can pose
major issues for hazard characterization.
0014 Animal experiments provide information on
dosage at which no ill effects occur in the test animals;
this is referred to as the ‘no observed effect level.’ A
dose–response assessment would then need to ex-
trapolate this animal data. There is much uncertainty
in this, because the nature of the hazard and mode of
human metabolism may change with dose, and the
response in humans may be different to that of the
experimental animals used. These uncertainties are
compensated for with the use of safety factors. Fre-
quently, a multiplication factor of 10 is used to ac-
commodate the differences between how humans and
animals might react to the hazard. Another factor of
10 is typically used to take account of the fact that
some humans are more sensitive than others to the
hazard in question. This yields an ‘acceptable daily
intake’ (ADI) figure. If dietary exposure is below
the ADI, it is assumed that there will be no ill effect.
This is known as the ‘threshold approach.’ For geno-
toxic carcinogens, this approach is not considered
appropriate, as it is assumed that there is a finite
risk, even with the lowest possible dose. In such
cases, a level of negligible/acceptable risk is set, fre-
quently at one in a million.
0015Exposure assessment is carried out using diet
studies. Direct monitoring of residues of the chemical
hazard (e.g., organochlorine pesticides) in human
tissues and body fluids is also gaining importance as
a means of exposure assessment.
0016Risk characterization then draws on the outputs of
hazard identification, hazard characterization, dose–
response assessment, and exposure assessment to
derive an estimate of the likelihood of adverse health
effects in human populations as a consequence of the
exposure. For threshold-acting hazards, risk is char-
acterized by comparing exposure to ADI. Risk is
notionally zero if exposure is lower than ADI. For
nonthreshold acting hazards, risk is calculated as a
function of exposure and potency.
0017As an example of how such a risk assessment can
be used, a study may be carried out on the existing or
proposed use of an agricultural or veterinary chem-
ical in association with food-production animals.
If the estimated risks are deemed unacceptable,
consideration can be given to various possible risk-
mitigation measures, such as means of reducing ex-
posure. If the risks can be reduced to an acceptable
level through such means, the chemical may be con-
sidered for registration. The setting of ‘safe/tolerance
levels’ for various chemical residues in food is another
application of risk assessment of chemical hazards.
Risk Assessment of Biological Hazards
0018Biological hazards include pathogenic strains of bac-
teria, viruses, helminthes, protozoa, and algae. Some-
times, toxins that some of these organisms may
produce, e.g., enterotoxins produced by Staphylococ-
cus aureus when growing to high numbers in food, are
also grouped with biological hazards. Of these, food-
borne pathogenic bacteria and viruses present, are by
far, the greatest concerns in regard to food safety.
0019Microbiological risk assessment follows basically
the same framework as chemical risk assessment.
However, it has its unique set of difficulties and chal-
lenges. The list of foodborne pathogens is extensive,
and pathogens can be found in abundance in the
natural environment, including that for the produc-
tion, harvesting, processing, storage, transportation,
display, retail, and preparation of food. Some of the
microbiological hazards, e.g., bacteria, can multiply
rapidly in the food as it goes through the production
and supply chain, whereas others can also produce
toxins or form heat-resistant spores under certain
conditions. The survival and proliferation of these
5016 RISK ASSESSMENT