WASHINGTON — The US Food and Drug Administration on Aug. 5 issued final guidance for inorganic arsenic in infant rice cereal. The FDA identified an action level at 100 micrograms per kilogram (2.2 lbs) or 100 parts per billion (ppb). The FDA gave the guidance because inorganic arsenic is associated with neurodevelopmental effects.
The final guidance may be found here.
Rice intake, primarily through infant rice cereal, is about three times greater for infants than adults in relation to body weight, according to the FDA. Rice and rice products also are a greater potential source of dietary inorganic exposure for infants and children than for adults since the dietary patterns of infants and children often are less varied than the dietary patterns of adults, according to the FDA.
The FDA said testing of infant rice cereal suggests manufacturers are making progress in reaching the 100 ppb level through good manufacturing practices like selective sourcing and testing of rice and rice-derived ingredients. Results from sampling in 2018 showed 76% of samples were at or below the 100 ppb level, which compared to 47% in 2014 and 36% between 2011-13.
The final guidance comes after the FDA issued draft guidance in the April 6, 2016, issue of the Federal Register. The FDA will accept either electronic or written comments on the final guidance. All submissions must include the Docket No. FDA-2016-D-1099 for “Inorganic Arsenic in Rice Cereals for Infants: Action Level; Guidance for Industry.”
Electric comments may be sent at www.regulations.gov. Written comments may be sent to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.