The U.S. Food and Drug Administration (FDA) has issued draft guidance proposing an action level of 100 µg/kg for inorganic arsenic in rice cereals for infants.

The agency has also released supporting documentation for its proposal as well as a risk assessment that includes (i) “a quantitative estimate of lung and bladder cancer risk from long-term exposure to these products and the predicted impact of various scenarios to reduce the risk,” and (ii) “a qualitative assessment of certain potential non-cancer risks, in certain susceptible life stages.”

“We conclude that the 100 µg/kg action level will help protect the public health and is achievable with the use of current good manufacturing practice, but we especially welcome comments and information bearing on the achievability and public health benefits and risks of 100 µg/kg, as compared with other potential action levels (including no action level),” states FDA, which will consider comments submitted by July 5, 2016. “If the guidance is finalized consistent with the draft, we intend to consider the action level of 100 µg/kg or 100 ppb inorganic arsenic, in addition to other factors, when considering whether to bring enforcement action in a particular case.” See Federal Register, April 6, 2016

Meanwhile, in an April 1, 2016, statement, U.S. Rep. Rosa DeLauro (D-Conn.) called on FDA to set action levels for inorganic arsenic in all rice products, not just infant rice cereals.

“The FDA’s new draft guidance for limiting the levels of inorganic arsenic found in infant rice cereal is a great first step in protecting the health of infants and I am pleased that the agency is finally taking action on this important public health issue,” DeLauro said. “However, the new guid- ance does not go far enough in ensuring the health of all Americans… The FDA should immediately expand the guidance to include proposed action levels on all rice based products. In the meantime, Congress should pass the Reducing food-based Inorganic Compounds Exposure (RICE) Act, which would do just that.”