Thursday, July 17, 2014

FDA reopens comment period on Reportable Food Registry proposed rulemaking

    The US Food and Drug Administration (FDA) has reopened the comment period for an additional 60 days on its advance notice of proposed rulemaking entitled, “Implementation of the Food and Drug Administration Food Safety Modernization Act (FSMA) Amendments to the Reportable Food Registry (RFR) Provisions of the Federal Food, Drug, and Cosmetic Act.” In the advance notice of proposed rulemaking, FDA requested comments, data and information that will help to implement the new provisions to the RFR requirements added by FSMA.
    The RFR is an electronic portal for industry to use to submit reports to FDA regarding reportable foods. A reportable food is an article of food (other than dietary supplements or infant formula) for which there is a reasonable probability that use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals. On March 26, 2014, FDA published a Federal Register notice inviting comments on issues related to the FSMA amendments, including the following:
    • what information responsible parties should be required to provide FDA that would enable consumers to accurately identify whether they possess such foods
    • manners and locations used by grocery stores to provide food recall information to consumers
    • information regarding potential impacts to and costs incurred by chain grocery stores related to posting consumer notifications
    The agency is reopening the comment period based on a request for an extension to allow interested persons additional time to submit comments. You may comment electronically on www.regulations.gov using docket number FDA-2013-N-0590.

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