The U.S. Food and Drug Administration (FDA) has proposed limiting the amount of inorganic arsenic allowed in infant rice cereal to 100 parts per billion (ppb). This action is consistent with the level set by the European Commission (EC) for rice intended for the production of food for infants and young children. Rice cereal is a leading source of arsenic exposure in infants. The FDA testing found that the majority of infant rice cereals currently on the market either meet, or are close to, the proposed action level.
The FDA announced the availability of the following documents: 1) a draft guidance for industry entitled Inorganic Arsenic in Rice Cereals for Infants: Action Level; 2) a supporting document entitled Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infant; and 3) a risk assessment report entitled Arsenic in Rice and Rice Products Risk Assessment Report. The draft guidance identifies an action level for inorganic arsenic of 100 ppb and outlines the FDA’s intended sampling and enforcement approach. The supporting document reviews data on inorganic arsenic levels in rice cereals for infants, health effects, achievability of the proposed limitation and explains the FDA’s rationale for identifying the 100 ppb action level. The risk assessment report includes quantitative and qualitative components assessing the cancer risks of long term exposure to inorganic arsenic in rice and rice products.
Arsenic is present in the environment as a naturally occurring substance or as a result of contamination from human activity such as contributions from fertilizers and pesticides. The FDA focused on rice and rice products because arsenic levels tend to be higher in these foods and rice products are common in the average American diet. FDA sampling indicates that the presence of inorganic arsenic varies widely among and within different categories of rice grain and products made from rice grain, generally ranging from less than 1 to as many as 545 ppb. Rice has higher levels of inorganic arsenic than other foods because as rice plants grow, the plant and grain tend to absorb arsenic from the environment more than other crops.
The FDA believes that the 100 ppb action level will help protect the public health and is achievable with the use of current good manufacturing practices. The FDA published its Notice of Availability, 81 Fed. Reg. 19976 (April 6, 2016), and opened a public comment period on the draft guidance, supporting document and risk assessment report until July 5, 2016.