FDA proposing limit on arsenic in infant rice cereal

By Stephen Davies

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WASHINGTON, April 1, 2016 - About half of the infant rice cereal on the market now would meet a new limit on inorganic arsenic proposed by the Food and Drug Administration.

FDA said it is proposing the limit in order to “reduce the possible risks of neurodevelopmental and other health effects.”

The proposal is in the form of a draft industry guidance, which was released today but has yet to be published in the Federal Register. Along with the proposal, FDA released a long-awaited risk assessment on arsenic in rice. The agency will take comments for 90 days once the guidance is officially published.

“Rice and rice-based food products have higher levels of inorganic arsenic than do other foods tested by FDA, and given their widespread consumption, are a major food source of inorganic arsenic,” FDA said in its guidance. “Rice tends to have higher arsenic concentrations than other cereal crops (such as wheat and barley), because of its ability to take up arsenic from soil and water and because it is typically grown under flooded conditions, which increase the potential for arsenic uptake.”

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“Relative to body weight, rice intake for infants, primarily through infant rice cereal, is about three times greater than for adults,” FDA said in its press release. “Moreover, national intake data show that people consume the most rice (relative to their weight) at approximately 8 months of age.”

The proposal neither surprised nor displeased the USA Rice Federation. “It doesn't come as a shock,” spokesperson Michael Klein said. “The level doesn't give us any pause.”

Klein cited FDA's announcement, which said tests in 2014 showed that “approximately 47 percent of infant rice cereal samples on the market in 2014 could meet a 100 ppb (parts per billion) hypothetical limit,” and that 78 percent were within the margin of error.

Gerber Products, which controls about 80 percent of the market for infant rice cereal, already meets the 100 ppb action level, Klein said.

He added that the industry has spent about $3 million over the past four years trying to figure out how arsenic gets into rice, but so far has not been able to deduce the answer. “There doesn't seem to be a correlation between the amount of arsenic in soil and arsenic in the plant,” he said.

Rep. Rosa DeLauro, D-Conn., called the draft guidance “a great first step in protecting the health of infants,” but called on FDA to expand it “to include proposed action levels on all rice based products.”

“What about two-year olds and three-year olds? What about expectant mothers? This is about the health and well-being of our families,” she said.

Consumer Reports, which first reported on arsenic in the food supply when it identified its presence in apple and grape juice in 2011, said the limit should be 90 ppb.

“While Consumer Reports is pleased to see that the FDA has finally proposed a limit on arsenic in infant rice cereal, and it is close to the level we recommended more than three years ago, we remain concerned that so many other rice-based products consumed by children and adults remain without any standards at all,” said Urvashi Rangan, executive director of the Consumer Reports Food Safety & Sustainability Center.

“This is particularly true of children's ready-to-eat cereals,” Rangan said. “We believe the FDA can act swiftly to protect public health and set levels on these products based on the risk the agency has acknowledged in its announcement today, and we intend to continue to push them on behalf of consumers to do so.”

Klein said consumers get more arsenic in their diets from fruits and vegetables than they do from rice. His organization's arsenicfacts.com says, “Rice is actually not the greatest source of arsenic in the typical diet. Fruit, fruit juice, and vegetables are greater sources of arsenic and few nutritionists and dietitians would advise you to eliminate these important sources of vitamins and minerals from your diet.”

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Good manufacturing practices, particularly selective sourcing, could allow all manufacturers to meet the 100 ppb level, FDA said. But it will be asking for comments on whether the limit is achievable and the effect it will have on the availability of infant rice cereal.

Right now, FDA does not appear to have a good handle on how the new limit would affect availability. “Were we to set a maximum level of 100 ppb in these foods, the availability in the marketplace might decrease by 4% to 93%, depending on the type of rice,” FDA said.

The proposed limit “is parallel to the level set by the European Commission (EC) for rice intended for the production of food for infants and young children,” FDA said, noting that the EC standard applies to the rice itself, while FDA's proposed guidance sets a draft level for inorganic arsenic in infant rice cereal.

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