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Consumption of inorganic arsenic has been associated with cancer, skin lesions, cardiovascular disease, and diabetes in humans (Refs.

Arsenic is found in both inorganic and organic forms (together referred to as total arsenic), and inorganic arsenic is generally considered more toxic than organic arsenic (Ref. The 100 micrograms per kilogram (μg/kg) or 100 parts per billion (ppb) action level for inorganic arsenic in infant rice cereals is identified in the FDA Guidance for Industry entitled “Inorganic Arsenic in Rice Cereals for Infants: Action Level.” FDA believes that the action level for inorganic arsenic in infant rice cereals will help protect public health by reducing infants’ dietary exposure to inorganic arsenic and is achievable with the use of current good manufacturing practices.Īrsenic is an element that occurs in the environment from both natural and manmade sources, including erosion of arsenic-containing rocks, volcanic eruptions, contamination from mining and smelting ores, and previous or current use of arsenic-containing pesticides (Ref. The purpose of this document is to present the background and rationale for FDA’s action level for inorganic arsenic in rice cereals for infants (hereafter referred to as infant rice cereals). Risk Assessment and Achievability Assessment Results.More Chemical Contaminants, Metals, Natural Toxins & Pesticides Guidance Documents & Regulations.Arsenic in Rice and Rice Products Risk Assessment.Guidance for Industry: Action Level for Inorganic Arsenic in Rice Cereals for Infants.