Transcript Food Additives

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
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FSMA
Enacted by Congress and signed into law by President
Obama on January 4, 2011
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FSMA Amends the Food, Drug and Cosmetic Act
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 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
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
* * * *
United States Agent
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”
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FSMA Amends the Food, Drug and Cosmetic
Act to Impose New Fees
Latest Developments
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
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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
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201120122013201420152016-
600 Foreign inspections
1,200 Foreign Inspections
2,400 Foreign Inspections
4,800 Foreign Inspections
9,600 Foreign Inspections
19,200 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.
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Other Recent Changes By FSMA Affecting Customs
Brokers, Freight Forwarders and Importers
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, 2011. Importers will be required to
establish programs to verify the safety of all
shipments of imported food .
 June 20, 2012. FDA may establish a Qualified
Importer program.
 October-December 2012. Facility Registration and
renewal.
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