The FDA, United States Food and Drug Administration extended the submissions of comments, scientific data and other information in connection with its draft for guidance for industry titled “Arsenic in Apple Juice: Action Level”.
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The deadline will be extended by 60 days and the new deadline is set for November 12, 2013.
This draft guidance identifies an action level for inogranic arsenic in apple uice for the industry. The FDA considers protective of human health and achievable with the use of good manufacturing practices. The draft guidance also describes the FDA’s Intended sampling and enforcement approach.
A notice of availability for the draft guidance was published in the Federal Register of July 15, 2013 (78 FR 42086) and included a request for comments.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The draft guidance proposes an action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice.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a news release, the agency’s “Draft Quantitative Assessment of Inorganic Arsenic in Apple Juice,” the agency’s “Draft Guidance for Industry on Arsenic in Apple Juice: Action Level,” and other, related materials.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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Source: Santa Clarita News