Wednesday, September 25, 2013

Join FDA in Miami to Discuss Major FSMA Proposed Rules


The U.S. Food and Drug Administration (FDA) announced it will hold two additional public meetings to discuss the Food Safety Modernization Act (FSMA) Proposed Rules on Foreign Supplier Verification Programs (FSVP) and the Accreditation of Third-Party Auditors/Certification Bodies
The two proposed rules are designed to strengthen assurances that imported food meets the same safety standards as food produced domestically.  The FSVP proposal provides requirements for importers to verify that their foreign suppliers are implementing the modern, prevention-oriented food safety practices called for by the FSMA, and achieving the same level of food safety as domestic growers and processors. This will create a new burden for importers to know and trust their manufacturers.  I believe we can expect to see enforcement and penalties from FDA - if you have not met your manufacturer yet, now is the time!
The second proposed rule on the Accreditation of Third-Party Auditors/Certification Bodies provides for the strengthening of quality, objectivity, and transparency of foreign food safety audits on which many U.S. food companies and importers currently rely to help manage the safety of their global food supply chains.
The purpose of the FDA’s public meetings is to solicit public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules.
If you are interested in commenting on these proposed rules, contact me to discuss the process. Please note the timeline below to submit comments to the FDA. 
These two added meetings will take place in Miami, FL and Long Beach, CA.

  • Miami meeting - October 10-11, 2013, at the Hyatt Regency Miami, 400 SE Second Avenue, Miami, FL 33131.
October 10, 2013
8:30 a.m. – 5:00 p.m.
October 11, 2013
8:30 a.m. – 12:30 p.m.  

  • Long Beach meeting - October 22-23, 2013, at the Hilton Long Beach & Executive Meeting Center, 701 West Ocean Boulevard, Long Beach, CA  90831
October 22, 2013
8:30 a.m. – 5:00 p.m.
October 23, 2013
8:30 a.m. – 12:30 p.m.
Please note the following important dates for the meetings in Miami, FL and Long Beach, CA:

  • Meeting in Miami, FL

    • September 24, 2013: Closing date for request to make oral comment

    • September 24, 2013: Closing date to request special accommodation due to a disability

    • October 1, 2013: Closing date for advance registration

  • Meeting in Long Beach, CA

    • October 1, 2013: Closing date for request to make oral comment

    • October 1, 2013: Closing date to request special accommodation due to a disability

    • October 8, 2013: Closing date for advance registration

  • November 26, 2013: Closing date to submit either electronic or written comments to FDA’s Division of Dockets Management; for the proposed rule on Foreign Supplier Verification Programs, see Docket No. FDA-2011-N -0143. For the proposed rule on Accreditation of Third-Party Auditors/Certification Bodies, see Docket No. FDA-2011-N-0146.
If you manufacture or import food products you MUST stay on top of FSMA and the new rules FDA will implement.  For assistance in commenting on these important new changes, contact me.  See you at the Miami meeting.

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