New FDA Regulations and Fees Impacting Customs Brokers, Freight Forwarders and Imported Food Presented by Russell K. Statman, Esq. Executive Director, Registrar Corp October 2011

FSMA Enacted by Congress and signed into law by President Obama on January 4, 2011 FSM

FSMA Amends the Food, Drug and Cosmetic 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 FSM

New FSMA “User Fees” Effective October 1, 2011 May be Charged to: Importers Food Manufacturers “U.S. Agents”

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 facility’s FDA registration

United States Agent ********

 Foreign food facilities designate their 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)

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”

FSM FSMA Amends the Food, Drug and Cosmetic Act to Impose New Fees

Latest Developments

 FDA Hourly Rate For Reinspections and Reconditioning:  $224 per hour, domestic  $325 per hour if foreign travel is required

“Reinspection” Fees Fee is based on the number of direct hours, including:  time spent conducting the physical surveillance at the facility,  whatever components of such an inspection are deemed necessary  making preparations and arrangements for the reinspection

“Reinspection” Fees Also includes time incurred:  Traveling  preparing any reports,  analyzing any samples  examining any labels if required  performing other activities until the facility is in compliance.

FSMA Foreign Facility Inspection Schedule  Foreign inspections  ,200 Foreign Inspections  ,400 Foreign Inspections  ,800 Foreign Inspections  ,600 Foreign Inspections  ,200 Foreign Inspections

Reconditioning Fees  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 the hourly rate ($224/$325)

Reconditioning Fees Reconditioning fees include:  Arranging for, conducting and reviewing tests of the reconditioned product  Examinations of labeling  All time incurred by FDA in evaluating the reconditioning proposal and reconditioned product

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 the shipment is not adulterated.

Fees Related to Import Alerts (DWPE) 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.

New FDA User Fees Not Complying with a Recall Order  Not initiating a recall as ordered by FDA  Not conducting the recall in the manner specified by FDA  Not providing FDA with information regarding the recall as ordered by FDA.

Other Recent Changes By FSMA Affecting Customs Brokers, Freight Forwarders and Importers FSM

Prior Notice  Filers need to indicate whether a food product has been refused entry to another country

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”

Looking Ahead December 22, Importers will be required to establish programs to verify the safety of all shipments of imported food.  June 20, FDA may establish a Qualified Importer program.  October-December Facility Registration and renewal.

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