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FDA Updates 4 Proposed Rules Implementing FSMA

The Food and Drug Administration (FDA) today made available proposed revisions to four (of seven) proposed rules implementing the FDA Food Safety Modernization Act (FSMA).  The proposed revisions address:

  1. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (for a summary, click here);
  2. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (for a summary, click here);
  3. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (for a summary, click here); and
  4. Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (for a summary, click here).

The proposed revisions derive from feedback received by FDA from the public during meetings and in tens of thousands of comments submitted on the proposed rules.

The proposed revisions will be published in the Federal Register on September 29, 2014.  FDA will accept comments on the proposed revisions of the four proposed rules for 75 days, while continuing to review comments already received on the portions of the proposed rules that are staying the same.  It has stated that it will not consider comments outside of the scope of the revisions to the original proposed rules.  The agency will consider both sets of comments before issuing final rules in 2015.

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