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FDA Extends Comment Period for Proposed “action level� for Arsenic in Apple Juice

CFSAN Constituent Update

September 12, 2013

The U.S. Food and Drug Administration (FDA) has extended by 60 days the period for submission of comments, scientific data and other information in connection with its draft guidance for industry titled “Arsenic in Apple Juice: Action Level.” The new deadline is November 12, 2013.

The draft guidance identifies for the industry an action level for inorganic arsenic in apple juice that the FDA considers protective of human health and achievable with the use of good manufacturing practices. It also describes the FDA’s intended sampling and enforcement approach.

A notice of availability for the draft guidance was published in the Federal Register of July 15, 2013 (78 FR 42086) and included a request for comments. The FDA has extended the comment period deadline in response to a request for an extension to allow interested persons additional time to submit comments.

The draft guidance proposes an action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice. This is the same level set by the U.S. Environmental Protection Agency for arsenic in drinking water.

The FDA would take the action level into account when considering an enforcement action..

Additional information concerning the proposed action level is posted on the FDA’s web site, including a news release, the agency’s “Draft Quantitative Assessment of Inorganic Arsenic in Apple Juice,” the agency’s “Draft Guidance for Industry on Arsenic in Apple Juice: Action Level,” and other, related materials. To access these documents, visit the agency’s Arsenic in Apple Juice main page.

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