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GUIDANCE DOCUMENT

Draft Guidance for Industry: Action Level for Inorganic Arsenic in Rice Cereals for Infants April 2016

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2016-D-1099
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

This draft guidance document provides information to manufacturers on the action level for inorganic arsenic in rice cereals for infants (hereafter referred to as infant rice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

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.  

Note: 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. These levels serve as guidance to FDA field staff. FDA will establish an action level, as opposed to a tolerance or regulatory limit (which must be established by rulemaking), 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, FDA will consider action levels, in addition to other factors, when considering whether to bring enforcement action in a particular case.

Download the Draft Guidance

Supporting Document

Arsenic in Rice and Rice Products Risk Assessment

More on Arsenic in Rice


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-1099.