FDA Proposes Limit for Inorganic Arsenic in Infant Rice Cereal

04 Apr 2016 --- The U.S. Food and Drug Administration is taking steps to reduce inorganic arsenic in infant rice cereal, a leading source of arsenic exposure in infants. 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.

Through a draft guidance to industry, the FDA is proposing a limit or “action level” of 100 parts per billion (ppb) for inorganic arsenic in infant rice cereal. 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.) FDA testing found that the majority of infant rice cereal currently on the market either meets, or is close to, the proposed action level.

“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, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “The proposed limit is a prudent and achievable step to reduce exposure to arsenic among infants.”

The agency expects manufacturers can produce infant rice cereal that meet or are below the proposed limit with the use of good manufacturing practices, such as sourcing rice with lower inorganic arsenic levels. The FDA takes an action level into account when considering an enforcement action.

Advice for Consumers
The FDA continues to advise all consumers to eat a well-balanced diet for good nutrition and to minimize potential adverse consequences from consuming an excess of any one food. The agency 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 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.

Also based on the FDA’s findings, it would be prudent for pregnant women to consume a variety of foods, including varied grains (such as wheat, oats, and barley), for good nutrition. This advice is consistent with long-standing nutrition guidance to pregnant women from the American Congress of Obstetricians and Gynecologists to have half of their grains consist of whole grains.

Published studies, including new research by the FDA, indicate that cooking rice in excess water (from six to 10 parts water to one part rice), and draining the excess water, can reduce from 40 to 60 percent of the inorganic arsenic content, depending on the type of rice – although this method may also remove some key nutrients.

Basis for Proposed Limit and Consumer Advice
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 is releasing data showing the levels of inorganic arsenic in 76 samples of rice cereals for infants. The FDA’s data show that nearly half (47 percent) of infant rice cereals sampled from retail stores in 2014 met the agency’s proposed action level of 100 ppb inorganic arsenic and a large majority (78 percent) was at or below 110 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. The agency found all the non-rice foods to be well below 100 ppb inorganic arsenic, showing that other low- arsenic options are available to be incorporated into a well-balanced diet.

In addition to evaluating the health risks discussed above, the agency developed a mathematical model for lung and bladder cancer outcomes associated with consumption of inorganic arsenic in rice and rice products. The FDA estimates that exposure to inorganic arsenic in rice and rice products causes an additional four cases of lung and bladder cancer over the lifetime for every 100,000 people in the United States. This estimate would account for far less than 1 percent of the nation’s lung and bladder cancer cases.

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.

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.

Next Steps
The agency is accepting public comments on the proposed action level and the risk assessment for 90 days. The Federal Register notice will be forthcoming.

A manufacturer may choose to implement the recommendations in a draft guidance before the guidance becomes final.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.