new fda regulations and fees impacting customs brokers, freight forwarders and imported food

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

FSMAEnacted 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

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

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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

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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 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

2011- 600 Foreign inspections

2012- 1,200 Foreign Inspections

2013- 2,400 Foreign Inspections

2014- 4,800 Foreign Inspections

2015- 9,600 Foreign Inspections

2016- 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.

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

Importers

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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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