APVMA Risk Assessment Manual, human health

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Assessing risks to human health

Protecting the health and safety of people from risks associated with agricultural and veterinary (agvet) chemicals involves both the assessment and the management of risks from the potential sources of exposure. Note that while reference is made to agvet chemicals in this document, the human health risk assessment will also consider biological agents for example whole microorganisms (including bacteria, fungi and viruses), immunobiological products and crude extracts of plants.

The assessment of risk is conducted in three steps:

1. the hazard assessment determines how inherently dangerous a chemical is to human health using primarily toxicity studies on animals, and in vitro studies (tests on tissue or cell cultures)
2. the exposure assessment determines the way and the extent to which the chemical users, workers or the public may be exposed to an agvet chemical. Human exposure data are used where available, but if not, various exposure modelling techniques are used
3. the overall risk assessment is a function of exposure and hazard that permits appropriate risk management initiatives, including label directions, to be established.