U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

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The U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) presents many important changes for companies exporting food to the United States.

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U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

  1. 1. The U.S. FDA Food Safety Modernization Act(For Exporters to the USA) Russell K Statman, Esq. Executive Director Registrar Corp
  2. 2. Food Safety Modernization Act Enacted by Congress and signed into law by President Barack Obama on January 4, 2011 11/1/2012
  3. 3. FSMA Amends the Food, Drug & Cosmetic Act 11/1/2012
  4. 4. FDA Food Safety Modernization Act Intended to Modernize U.S. Food Safety System, including stricter controls on imported food Implemented in Phases through January 2016 Timeline handout provided by Registrar Corp 11/1/2012
  5. 5. Registration Suspension FDA may suspend the registration of food facilities (effectively closing them from the U.S. market) Registration may be held in suspension until FDA determines that no further health consequences exist. FDA may require “corrective action plans” 11/1/2012
  6. 6. New FSMA “User Fees” Effective October 1, 2011 May be Charged to:  Importers  Food Manufacturers  “U.S. Agents” 11/1/2012
  7. 7. FSMA Reinspection Fees May be charged to the facility’s designated “U.S. Agent” That could be YOU – if you have been designated as the “U.S. Agent” by a foreign food facilty’s FDA registration 11/1/2012
  8. 8. United States Agent 11/1/2012
  9. 9. United States Agent 11/1/2012
  10. 10. 11/1/2012
  11. 11. U.S. Agent Food facility designates a “U.S. Agent” under the regulation when they first register with FDA The U.S. Agent is designated in Section 7 of the registration form Typically, registration and designation is performed electronically through the FDAs FFRM (Food Facility Registration Module) 11/1/2012
  12. 12. United States Agent U.S. Agents have been designated since 2003, and foreign companies have not had to update that information since the initial designation Since 2003, many customs brokers and importers have allowed foreign companies to designate them as the required “U.S. Agent” 11/1/2012
  13. 13. FSMA Amends the Food, Drug & Cosmetic Act to Impose New Fees 11/1/2012
  14. 14. Latest Developments 11/1/2012
  15. 15. Fee Rates FDA Hourly Rate for Reinspection & Reconditioning:  $221 per hour, domestic  $289 per hour, if foreign travel is required 11/1/2012
  16. 16. Reinspection Fees Fee is based on the number of direct hours, including:  Time spent conducting physical surveillance at the facility  Whatever components of such an inspection are deemed necessary  Making preparations and arrangements for the reinspection 11/1/2012
  17. 17. Reinspection Fees Also include:  Traveling  Preparing any reports  Analyzing any samples  Examining any labels if required  Performing other activities until the facility is in compliance 11/1/2012
  18. 18. FSMA Foreign Facility Inspection Schedule Double the previous year, minimum of: 20000 19200 Year Foreign Number of Inspections Inspections 15000 2011 600 9600 2012 1,200 10000 2013 2,400 4800 5000 2014 4,800 2400 600 1200 2015 9,600 0 2016 19,200 Year 11/1/2012
  19. 19. Reconditioning Fees (For Products) Will be charged where reconditioning is required to bring food into compliance Fees must be paid by owner of food or importer, depending on circumstances Fees must be paid at hourly rate ($221/$289) Reconditioning fees include:  Arranging for, conducting and reviewing tests of reconditioned product  Examination of labeling  All time incurred by FDA in evaluating the reconditioning proposal and reconditioned product 11/1/2012
  20. 20. Prior Notice Filers need to indicate whether a food product has been refused entry to another country 11/1/2012
  21. 21. FDA Food Safety Modernization Act Record-keeping rules issued February, 2012 11/1/2012
  22. 22. Awaiting Regulations Were due January 4, 2012  Foreign supplier verification program  Preventative controls for human and animal food  Produce Safety  Third Party Auditors 11/1/2012
  23. 23. Later this year… October-December 2012  Facility Registration and renewal  Now Biennial (every even-numbered year) 11/1/2012
  24. 24. New FSMA User Fees Fees may be charged to:  Food manufacturers  Food Owner  Importers  “U.S. Agents” 11/1/2012
  25. 25. FSMA Reinspection Fees Will be charged for a follow-up reinspection if FDA’s initial inspection determines “Official Action Indicated” (OAI) Facility reinspection billed to the facility’s designated “U.S. Agent” 11/1/2012
  26. 26. Fees Related to Import Alerts (DWPE) Will be charged where food is detained by an Import Alert (DWPE) and proof is offered to show that shipment is not adulterated. FDA’s Informal Policy Statements Exporters applying for removal from DWPE must pay FDA’s hourly charges for evaluating the application including the cost of inspecting the foreign facility if necessary. 11/1/2012
  27. 27. Contact Us144 Research DriveHampton, VAUSA 23666P: +757-224-0177F: +757-224-0179E: info@registrarcorp.comW: www.registrarcorp.com 11/1/2012

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