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FDA proposes limit on arsenic in infant rice cereals

The US Food and Drug Administration (FDA) announced today that it wants to reduce the amount of inorganic arsenic in infant rice cereal to protect children from possible developmental problems.

The FDA released draft guidance for the food industry that sets a limit or action level of 100 parts per billion (ppb) for inorganic arsenic in this ubiquitous baby food. The agency also encourages parents to feed their infants a variety of iron-fortified cereals, and not only iron-fortified rice.

Pregnant women should diversify their grain consumption as well, because recent studies have linked intake of relatively high levels of inorganic arsenic to adverse pregnancy outcomes, the agency said in a news release. In addition, fetal exposure to inorganic arsenic together with dietary exposure during infancy can “result in a child’s decreased performance on certain developmental tests that measure learning.”

However, “consumers can certainly eat rice as part of a well-balanced diet,” the agency stated in a question-and-answer article on its website.

Reducing arsenic levels in rice is especially important for infants, the agency said, because relative to body weight, their intake of rice — primarily through cereal — is roughly three times greater than that for adults.

“Our actions are driven by our duty to protect the public health and our careful analysis of the data and the emerging science,” said Susan Mayne, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition, in the news release. “The proposed limit is a prudent and achievable step to reduce exposure to arsenic among infants.”

Cancer Risk Also Assessed

Good manufacturing practices, the agency said, can produce infant rice cereal that complies with the proposed arsenic limit. Most manufacturers are already close. Of 76 infant rice cereals recently tested by the FDA, 47% did not exceed the proposed limit of 100 ppb, and 78% were at or below 110 ppb. Nonrice foods for infants and toddlers, in contrast, tested well below 100 ppb.

The agency noted that inorganic arsenic found in rice cereal and other foods is not an additive or ingredient, but something naturally absorbed by all plants from water, soil, and air. Rice tends to absorb more arsenic than most. Unlike organic arsenic, inorganic arsenic is not bonded to carbon, and when found in food, it is the more toxic of the two forms.

As part of its risk assessment, the FDA mathematically modeled the incidence of lung and bladder cancer associated with consuming inorganic arsenic in rice and rice products. It estimated that this exposure causes an extra four cases of lung and bladder cancer over the lifetime for every 100,000 people in the United States, the agency said. “This estimate would account for far less than 1 percent of the nation’s lung and bladder cancer cases.”

The US Environmental Protection Agency, the National Institutes of Health, and the US Department of Agriculture reviewed the FDA’s risk assessment of inorganic arsenic, as did nongovernment experts.

Once the industry guidance regarding inorganic arsenic levels in infant rice cereal is published on the Federal Register, the FDA will accept public comments for 90 days.

More information on today’s announcement is available on the FDA website.