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Food Additives

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

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Title: Food Additives


1
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
2
FSM
FSMA Enacted by Congress and signed into law by
President Obama on January 4, 2011
3
FSMA Amends the Food, Drug and Cosmetic Act
FSM
4
FSM
  • 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

5
New FSMA User Fees Effective October 1, 2011
May be Charged to Importers Food
Manufacturers U.S. Agents
6
FSMA Reinspection Fees
  • May be charged to the facilitys designated U.S.
    Agent
  • That could be YOU ----- if you have been
    designated as the U.S. Agent by a foreign food
    facilitys FDA registration

7
United States Agent

8
United States Agent
9
(No Transcript)
10
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)

11
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

12
FSMA Amends the Food, Drug and Cosmetic Act to
Impose New Fees
FSM
13
Latest Developments
14
Latest Developments
  • FDA Hourly Rate For Reinspections and
    Reconditioning
  • 224 per hour, domestic
  • 325 per hour if foreign travel is required

15
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

16
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.

17
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

18
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)

19
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

20
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.
21
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.
22
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.

23
FSM
Other Recent Changes By FSMA Affecting Customs
Brokers, Freight Forwarders and Importers
24
Prior Notice
  • Filers need to indicate whether a food product
    has been refused entry to another country

25
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

26
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.

27
About Registrar Corp
28
Contact Us
Registrar Corp Headquarters 144 Research Drive
Hampton, Virginia USA 23666 P 757-224-0177
F 757-224-0179 E info_at_registrarcorp.com
W www.registrarcorp.com
29
Keep this link handy!
www.registrarcorp.com/livehelp
30
Registrar Corp
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