Draft Guidance for Industry: Inorganic Arsenic in Rice Cereals for Infants: Action Level


How to Comment

The comment period opens April 6, 2016.

Although you may comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 19, 2016.

Submit electronic comments on to docket number FDA-2016-D-1099.

Submit written comments to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2016-D-1099.

Contains Nonbinding Recommendations

Draft-Not for Implementation

This guidance is being distributed for comment purposes only. 

April 2016 

This draft guidance document provides information to manufacturers on the action level for inorganic arsenic in rice cereals for infants (hereafter referred to as infant rice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.

Draft Guidance for Industry
Inorganic Arsenic in Rice Cereals for Infants: Action Level
(PDF: 154KB)

This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

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.

Page Last Updated: 12/12/2016
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