On September 19, 2014 the U.S. Food and Drug Administration (FDA) made available revised versions of four draft rules which had been previously published and for which the comment period had closed. These draft rules were originally proposed in 2013 as part of FDA’s implementation of the Food Safety Modernization Act (FSMA). The revisions to these rules are a result of thousands of comments submitted to FDA during the comment period. These revised rules will be officially “published” by FDA on September 29, 2014 and FDA will accept comments to these revised draft rules for seventy-five (75) days thereafter.

The revised draft FSMA rules made available today include:

  • Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
  • Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption                                
  • Human Foods: Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls
  • Food for Animals: Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls

Pre-publication PDF versions of these revised draft rules can be found at the links below. The date for publishing the final rules remains unchanged.

Click here to view table.

FDA will hold a public meeting regarding these revised proposed rules on November 13, 2014 in College Park, Maryland, with details to be announced at a later date.