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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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The U.S. FDA Food Safety Modernization Act
(For Exporters to the USA)
Russell K Statman, Esq.
Executive Director
Registrar Corp
04/11/2023
Food Safety Modernization Act
Enacted by Congress and signed into law by President Barack Obama on January 4, 2011
04/11/2023
FSMA Amends the Food, Drug & Cosmetic Act
04/11/2023
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
04/11/2023
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”
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New FSMA “User Fees” Effective October 1, 2011
May be Charged to: Importers Food Manufacturers “U.S. Agents”
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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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United States Agent
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United States Agent
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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)
04/11/2023
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”
04/11/2023
FSMA Amends the Food, Drug & Cosmetic Act to Impose New Fees
04/11/2023
Latest Developments
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Fee Rates
FDA Hourly Rate for Reinspection & Reconditioning:$221 per hour, domestic$289 per hour, if foreign travel is required
04/11/2023
Reinspection Fees
Fee is based on the number of direct hours, including:Time spent conducting physical surveillance at the facilityWhatever components of such an inspection are deemed
necessaryMaking preparations and arrangements for the reinspection
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Reinspection Fees
Also include:TravelingPreparing any reportsAnalyzing any samplesExamining any labels if requiredPerforming other activities until the facility is in compliance
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FSMA Foreign Facility Inspection Schedule
Double the previous year, minimum of:
2011
2012
2013
2014
2015
2016
0
5000
10000
15000
20000
600 12002400
4800
9600
19200
Year
Num
ber
of I
nspe
ctio
ns
Year Foreign Inspections
2011 600
2012 1,200
2013 2,400
2014 4,800
2015 9,600
2016 19,200
04/11/2023
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 labelingAll time incurred by FDA in evaluating the reconditioning
proposal and reconditioned product
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Prior Notice
Filers need to indicate whether a food product has been refused entry to another country
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FDA Food Safety Modernization Act
Record-keeping rules issued February, 2012
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Awaiting Regulations
Were due January 4, 2012Foreign supplier verification programPreventative controls for human and animal foodProduce SafetyThird Party Auditors
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Later this year…
October-December 2012Facility Registration and renewalNow Biennial (every even-numbered year)
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New FSMA User Fees
Fees may be charged to:Food manufacturersFood OwnerImporters“U.S. Agents”
04/11/2023
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”
04/11/2023
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 StatementsExporters 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.
04/11/2023
Contact Us
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Hampton, VA
USA 23666
P: +757-224-0177
F: +757-224-0179
W: www.registrarcorp.com