Consumer exposure estimates migration

The second part of any risk assessment requires an estimate of consumer exposure to the migrating substance. This depends on a number of factors ... 

Migration studies can use food-simulating solvents, such as 10% ethanol to represent aqueous, acidic and low-alcohol foods, or food oil or 50% or 95% ethanol to represent fatty foods. Experimental temperature and duration are set at the most extreme anticipated conditions. For example, the most extreme condition requires heating at 121°C for 2h, followed by 10 days at 40°C, in a special cell designed to withstand the extremes of temperature and pressure. The FDA uses migration data to estimate consumer exposure to the substance. In the previous system, an application could take several years to get approval. With the FCN system, the FDA has 120 days to review the application and object based on safety grounds, or the substance may be marketed. Expectations were that the new system would result in many more applications for new products from companies that otherwise would not have tried marketing in food applications. ... 

Occupational exposures are low based on production in a closed system and its low vapor pressure. The estimated exposure levels to die general population via consumer products, i.e. migration of DEHA from food wraps, is estimated at exposures of 117 pg/kg/d. The highest measured surface water concentration was 0.001 mg/L. Both of these results are considered to be low as well. 

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