Those wishing to comment on draft guidance for industry on inorganic arsenic levels in rice cereals for infants have 14 more days to do so. The U.S. Food and Drug Administration announced Wednesday that, because of maintenance on the Federal eRulemaking portal, the comment deadline has been extended from July 5 to July 19.
The public is being asked to submit scientific data, information, and comments on the draft guidance, which appeared in the Federal Register on April 6. To electronically submit comments to the docket, go here. As of Wednesday, no public comments had been posted.
To submit comments by regular mail, use the following address: Division of Dockets Management, HFA-305, U.S. Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD, 20852. Be sure to include docket number FDA-2016-D-1099 on each page of your written comments.
According to FDA, inorganic arsenic in infant rice cereal is a leading source of arsenic exposure in infants.
“Relative to body weight, rice intake for infants, primarily through infant rice cereal, is about three times greater than for adults. Moreover, national intake data show that people consume the most rice (relative to their weight) at approximately 8 months of age,” the agency notes.
Through its draft guidance to industry, FDA is proposing a limit or “action level” of 100 parts per billion (ppb) for inorganic arsenic in infant rice cereal. This is parallel to the level set by the European Commission (EC) for rice intended for the production of food for infants and young children. However, the EC standard concerns the rice itself, while FDA points out that its proposed guidance sets a draft level for inorganic arsenic in infant rice cereal.
Agency testing has found that the majority of infant rice cereal currently on the market either meets, or is close to, the proposed action level.
“Our actions are driven by our duty to protect the public health and our careful analysis of the data and the emerging science,” said Susan Mayne, director of FDA’s Center for Food Safety and Applied Nutrition. “The proposed limit is a prudent and achievable step to reduce exposure to arsenic among infants.”
More information about inorganic arsenic in rice and rice products can be found on this FDA website.
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