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FDA seeks comments on inorganic arsenic in infant rice cereal

Having documenting that many rice cereals for infants and toddles have significant levels of inorganic arsenic — which can cause neurologic and developmental problems — the government is proposing a maximum allowable limit for the substance.

baby-boy-eating The U.S. Food and Drug Administration’s new draft guidance on inorganic arsenic levels pertains only to the substance in rice cereals for infants and toddlers, based on tests of almost 500 samples of so-called starter foods for youngsters.

“FDA is proposing a limit or ‘action level’ of 100 parts per billion (ppb) for inorganic arsenic in infant rice cereal,” according to FDA documents posted late last week.

“This is parallel to the level set by the European Commission (EC) for rice intended for the production of food for infants and young children. The EC standard concerns the rice itself; the FDA’s proposed guidance sets a draft level for inorganic arsenic in infant rice cereal.”

A 90-day comment will provide the opportunity for the public and industry to suggest changes to the FDA’s draft guidance for in organic arsenic in rice cereals for infants and toddlers. Details on how to comment and the draft guidance, as well as supporting materials, are available on the FDA’s website.

Rice cereals for infants and toddlers are of particular concern, according to the FDA, because of the disproportionate amount of rice that age group consumes.

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

The proposed limit stems from extensive testing of rice and non-rice products, a 2016 FDA risk assessment that analyzed scientific studies showing an association between adverse pregnancy outcomes and neurological effects in early life with inorganic arsenic exposure, and an evaluation of the feasibility of reducing inorganic arsenic in infant rice cereal.

The FDA found that inorganic arsenic exposure in infants and pregnant women can result in a child’s decreased performance on certain developmental tests that measure learning, based on epidemiological evidence including dietary exposures.

The FDA tested levels of inorganic arsenic in 76 samples of rice cereals for infants collected from retail stores. Less than half of those, 47 percent, met the agency’s proposed action level of 100 ppb inorganic arsenic.

To assess if there were other sources of inorganic arsenic in infant foods, the FDA also tested more than 400 samples of other foods commonly eaten by infants and toddlers. All the non-rice foods were well below 100 ppb level for inorganic arsenic, showing that other low-arsenic options are available to be incorporated into a well-balanced diet.

The nature of rice and inorganic arsenic
Arsenic is an element in the Earth’s crust and is present in water, air and soil. Arsenic is naturally occurring in the soil and the water. Fertilizers and pesticides also contribute to levels.

Arsenic exists in two forms, organic and inorganic. When encountered in the diet, inorganic arsenic is considered to be the more toxic of the two forms. Rice has higher levels of inorganic arsenic than other foods, in part because as rice plants grow, the plant and grain tend to absorb arsenic from the environment more than other crops.

The FDA’s scientific assessment of possible adverse health effects associated with inorganic arsenic was subjected to external peer review as well as review by other government agencies, including the U.S. Environmental Protection Agency, the U.S. Health and Human Services’ National Institutes of Health, and the U.S. Department of Agriculture.

The FDA reported that manufacturers should be able to produce infant rice cereals that meet or are below the proposed limit with the use of good manufacturing practices, such as sourcing rice with lower inorganic arsenic levels.

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Advice for consumers
The government is not advising the general population of consumers to change their current rice consumption patterns based on the presence of arsenic, but is providing targeted information for pregnant women and infants to help reduce exposure.

The agency recognizes that infant rice cereal is a common “starter” food for infants and notes that the American Academy of Pediatrics specifically encourages consumption of iron-fortified cereals for infants and toddlers.

Based on the FDA’s findings with respect to inorganic arsenic in rice, the agency offers the following advice to parents and caregivers of infants:

• Feed your baby iron-fortified cereals to be sure she or he is receiving enough of this important nutrient.

• Rice cereal fortified with iron is a good source of nutrients for your baby, but it shouldn’t be the only source, and does not need to be the first source. Other fortified infant cereals include oat, barley and multigrain.

• For toddlers, provide a well-balanced diet, which includes a variety of grains.

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