Guidance for Industry: Action Level for Inorganic Arsenic in Rice Cereals for Infants

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This guidance provides information to manufacturers on the action level[2] for inorganic arsenic in rice cereals for infants (hereafter referred to as infant rice cereals) that is intended to help protect public health by reducing infants’ dietary exposure to inorganic arsenic and is achievable by industry with the use of current good manufacturing practices. This guidance applies to all types of infant rice cereals.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

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1 This guidance has been prepared by the Division of Plant Products and Beverages, Office of Food Safety, in the Center for Food Safety and Applied Nutrition at the Food and Drug Administration.
2 Under 21 CFR 109.4, when certain conditions are met, FDA may establish an action level for an added poisonous or deleterious substance to define a level of contamination at which a food may be regarded as adulterated, within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In this context, “added” does not mean added by the manufacturer, but rather resulting from the hand of man; for example, from previous pesticide use (see United States vs. Anderson Seafood, Inc. 622 F.2d 157 (5th Cir. 1980)). These action levels serve as guidance to FDA field staff and industry. We will establish an action level, as opposed to a tolerance or regulatory limit (which must be established by rulemaking (21 CFR 109.4)), when technological or other changes that might affect the appropriateness of the tolerance are foreseeable in the near future (21 CFR 109.6(d)). Consistent with 21 CFR 109.6, we will consider action levels, in addition to other factors, when considering whether to bring enforcement action in a particular case.

 

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