by Daniela Gonzalez
The FDA’s Center for Food Safety and Applied Nutrition in consultation with the National Institute of Environmental Health Sciences, the Centers for Disease Control and Prevention, the U.S. Department of Agriculture, the FDA National Center for Toxicological Research, and the Environmental Protection Agency conducted a risk assessment in 2014 to analyze the health risks associated with arsenic in rice and products that contain rice. The objectives of this risk assessment were to assess the risk of adverse health effects associated with exposure to arsenic from consumption of rice grain and rice products and to examine how that risk may be mitigated.
In its Risk Assessment Report the FDA explained its need to focus on arsenic in rice and rice based products by citing to a Total Diet Study—an ongoing survey of the average American diet that revealed that a large portion of the American diet is based on rice and rice based products and studies have shown that arsenic levels tend to be higher in these products than in other foods. In its Release, the FDA also addressed the need to explore the levels of inorganic arsenic in rice after studies revealed 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.
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 of arsenic in foods. There are two forms of arsenic in foods: inorganic and organic. Of the two types, the inorganic forms of arsenic have been more closely associated with adverse health effects. 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 Assessment Report evaluated the health risks associated with rice and rice products in two vulnerable populations: “(1) those exposed to arsenic while in the womb, through maternal intake of arsenic-containing rice and (2) early childhood, including infancy.” Infants are exposed to rice products either directly after birth or indirectly through maternal consumption. Fetuses may be increasingly susceptible to adverse health effects from maternal inorganic arsenic intake. The FDA news release states that “relative to body weight, rice intake for infants, primarily through infant rice cereal, is about three times greater than for adults.” The Assessment Report found that “the predicted risk of developing cancer at some point in life after having been exposed to inorganic arsenic in rice only during infancy increases with the frequency of weekly servings . . . .”
In adults, the study revealed that lung cancer and bladder cancer risk attributable to a lifetime exposure to rice and rice products are noted to be 10 cases per every million bladder cancer cases, and 29 cases per every million lung cancer cases. The FDA estimates that exposure to inorganic arsenic in rice and rice products causes an additional 4 cases of lung and bladder cancer over the lifetime for every 100,000 people in the United States.
While testing the concentration of inorganic arsenic in rice and rice based products, the FDA found the following average concentration of inorganic arsenic in: white rice – 92 parts per billion (ppb); brown rice – 154 ppb; infants dry white rice cereal – 104 ppb; and infants dry brown rice cereal – 119 ppb. Eliminating rice and rice products from infant’s diets as well as of children up to 6 years old could reduce the lifetime cancer risk from inorganic arsenic in rice and rice products up to 6% and 23%, respectively. In other words, the Assessment Report predicts that an infant that is not fed any rice or rice products has an approximately 6% lower chance of developing lung or bladder cancer from arsenic contamination of these foods, over their lifetime, compared with an infant who is fed these products.
As a result, the FDA has proposed a limit for inorganic arsenic in infant rice cereal. Setting a limit below 200 ppb of inorganic arsenic in rice and rice products would decrease the risk of cancer. For instance, “setting a limit of 150 ppb of inorganic arsenic in rice and rice products would decrease the risk between 0% and 23%”; setting a limit of 100 ppb of inorganic arsenic would equate a risk reduction between 2% and 47%; setting a limit at 75 ppb of inorganic arsenic in rice and rice products would decrease the risk between 17% and 79%.
The FDA tested the levels of inorganic arsenic in 76 samples of rice cereals for infants and found that nearly half, about 47%, of infant rice cereals sampled met the agency’s proposed action level of 100 ppb inorganic arsenic. These samples also revealed that a large majority, 78%, was at or below 110 ppb inorganic arsenic. However, it seems the FDA will face market disapproval for reducing the action level of inorganic arsenic in infant rice cereal. Setting a maximum level for inorganic arsenic in rice and rice products could affect availability in the U.S. market. If the FDA 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.
Despite the possible backlash the FDA will receive for limiting the inorganic arsenic in infant rice cereal, the risk assessment revealed a need to regulate these levels due to the adverse effects cause by inorganic arsenic levels. Through a draft guidance to industry, the FDA has proposed a limit or “action level” of 100 ppb for inorganic arsenic in infant rice cereal. Via this proposal, the FDA has taken the first step to regulate these levels. Now as part of the agency practice, the report will undergo public comment for 90 days. and the risk assessment will subsequently be revised. Manufacturers may, at this time, choose to implement the suggested limitations proposed by the FDA, before the guidance becomes final.
Daniela Gonzalez is a Staff Member at the FIU Law Review. Ms. Gonzalez can be reached at dgonz068@fiu.edu.