Risk Assessment saccharin

Risk assessment is a scientific process whereby the level and nature of the risk is determined. If there is no exposure to a particular chemical then there will be no risk at all, for example potassium cyanide in a sealed container is a hazard but not a risk. Risk can therefore be minimized if exposure is minimized. If the chemical is effectively non-hazardous, that is the amount needed to cause harm is unrealistically high, such as with common salt or saccharin, then even if there is a level of exposure, the risk will be so small as to be virtually non-existent. Therefore both the level of exposure and the nature of the chemical (whether or not it is hazardous) must be known if the risk is to be assessed. 

The safety evaluation study for saccharin, on which the risk assessment was based that allowed the FDA ban to be lifted, was made available in 1983. It established a relationship between the dose of saccharin and the appearance of bladder tumours in male rats (the response). While it was found that saccharin was able to cause tumours in rats, the following points were important considerations in the risk assessment. 

The example of saccharin shows how the risk assessment for a food additive is carried out, and the precautions taken by the regulatory authorities, using large safety factors and always erring on the side of caution (the precautionary principle). In this case there was human data available, unusually for a food additive. Today a new food additive would not be used in food for human consumption until it had been evaluated for safety in animals. 

Wysner, J. Wilhams, G.M. Saccharin mechanistic data and risk assessment urine composition, enhanced cell proliferation, and tumour promotion. Pharmacol. Ther. 1996, 71 (1-2), 225-252. 

A decade after the US EPA was established, a National Research Council report entitled Risk Assessment in the Federal Government Managing the Process was released in response to a directive from the US Congress to perform a study of the practices of risk assessment (PJ ) and risk management (RM). It mainly dealt with controversies related to IGA techniques (scientific basis) and their influence on regulatory actions and particularly policy decisions (RM). At the time, there were many pubHc concerns regardingIGA/RM related to the risk of cancer from exposure to chemicals present in the environment. There were also issues with the RA procedures supporting the control of asbestos, formaldehyde, and saccharin. 

NAS/NRC (1978). National Academy d Sdences/Naticnal Research CounciL Saccharin Tkchnical Assessment of Risks and Benefits, Part 1 of a 2-Part Study of... 

Hie artificial sweetener, saccharin, and the secondary mold product, aflatoxin Bj, are present in many foods consumed by humans. Both chemicals produce cancer in rats. For this reason, they have aroused concern among scientists and the public as to the carcinogenic risk that they pose to humans. A comparison of these two chemicals reveals striking contrasts in potency, metabolism, mechanism-of-action, and experimental approach to assessing metabolism. These contrasts are examined in detail to illustrate the importance of metabolism in safety evaluation. 

---