US FDA Proposes an Action Level for Inorganic Arsenic in Rice Cereal
SAFEGUARDS | FoodNO. 078/16
On April 1, 2016, the US food and Drug Administration (US FDA) issued a proposed action level for inorganic arsenic in infant rice cereals.  For this draft guidance  this action level will be established at 100 μg/kg (ppb), which is in line with the European Commission’s standard for rice for the production of food for infants and young children as per EU 1006/2015. 
The US FDA is proposing this inorganic arsenic level in order to reduce exposure to arsenic in infant diets. Infants, because of their low body weight and less varied diet, consume three times as much rice product and are therefore subjected to more inorganic arsenic from rice per body mass. The results of testing in the US FDA 2014 survey indicated that 47% of the infant rice cereals on the retail shelves would meet this proposed standard, and that 78% would meet a standard of 110 μg/kg.
The proposed limit stems from the US FDA’s testing of rice and non-rice products and risk assessments that analyzed scientific studies. These studies presented an association between adverse pregnancy outcomes and neurological effects in early life with inorganic arsenic exposure. Additionally, “the US FDA estimates that exposure to inorganic arsenic in rice and rice products causes an additional four cases of lung and bladder cancer over the lifetime for every 100,000 people in the United States”.
Arsenic is a naturally occurring element and is found in organic and inorganic forms. Inorganic arsenic when consumed is the more toxic form. Unfortunately, when growing, rice plants absorb more arsenic then other plants.
The US FDA is not suggesting that the general population reduce their consumption of rice and rice products, the suggestion is that pregnant women eat a balanced diet with a variety of grains, specifically whole grains, which is also consistent with the advice from the American Congress of Obstetricians and Gynecologists.
The comment period for this proposal is 90 days.
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