FDA To Hold Public Meeting on FSMA Supplemental Proposed Rules

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The Food and Drug Administration (FDA) has announced a public meeting to be held on November 13, 2014 to discuss its four supplemental proposed rules under the Food Safety Modernization Act (FSMA). On September 29, FDA published supplemental proposed rules for four of its “foundational” FSMA rulemakings:

  • Produce Safety
  • Preventive Controls for Human Food
  • Preventive Controls for Animal Food
  • Foreign Supplier Verification Programs

See our October 10th blog post on the supplemental proposed rules here.

Given the significant changes being proposed, a public meeting seems appropriate.  FDA officials have stated the agency may also schedule some listening sessions around the country during the comment period, which ends December 15, 2014, but these have not been announced yet.

The stated purpose of the meeting is to inform the public of the proposed changes and the rulemaking process, to respond to questions about the supplemental proposed rules, and to hear oral comments.  The public meeting is to discuss the supplemental proposed rules only.

The meeting will be held at the Food and Drug Administration’s Wiley Building, 5100 Paint Branch Parkway, College Park, MD 20740 on November 13, 2014 from 8:30 am to 5:00 pm. Early registration is recommended because of limited seating. The meeting also will be webcast live for those unable to attend in person.  Information about how to register to attend in person or via webcast, how to request a time slot to make an oral presentation, and other details can be found here.  Requests to make oral presentations must be submitted by October 27th.

A transcript of the meeting will become part of the administrative records in the four rulemakings.  The transcript and a video recording of the meeting will be made available on FDA’s FSMA website and at http://www.regulations.gov.

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