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.

1. The U.S. FDA Food Safety
Modernization Act
(For Exporters to the USA)
Russell K Statman, Esq.
Executive Director
Registrar Corp

2. Food Safety Modernization Act
 Enacted by Congress and signed into law by President
Barack Obama on January 4, 2011
11/1/2012

3. FSMA Amends the Food, Drug & Cosmetic Act
11/1/2012

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. 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. New FSMA “User Fees” Effective October 1, 2011
 May be Charged to:
 Importers
 Food Manufacturers
 “U.S. Agents”
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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
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8. United States Agent
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9. United States Agent
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10. 11/1/2012

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
FDA's FFRM (Food
Facility Registration
Module)
11/1/2012

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”
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13. FSMA Amends the Food, Drug & Cosmetic
Act to Impose New Fees
11/1/2012

14. Latest Developments
11/1/2012

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. 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
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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. 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. 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
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20. Prior Notice
 Filers need to indicate whether a food product has been
refused entry to another country
11/1/2012

21. FDA Food Safety Modernization Act
 Record-keeping rules issued February, 2012
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22. Awaiting Regulations
 Were due January 4, 2012
 Foreign supplier verification program
 Preventative controls for human and animal food
 Produce Safety
 Third Party Auditors
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23. Later this year…
 October-December 2012
 Facility Registration and renewal
 Now Biennial (every even-numbered year)
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24. New FSMA User Fees
 Fees may be charged to:
 Food manufacturers
 Food Owner
 Importers
 “U.S. Agents”
11/1/2012

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. 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. Contact Us
144 Research Drive
Hampton, VA
USA 23666
P: +757-224-0177
F: +757-224-0179
E: info@registrarcorp.com
W: www.registrarcorp.com
11/1/2012