u.s. fda food safety modernization act (fsma) seminar (english)

27
The U.S. FDA Food Safety Modernization Act (For Exporters to the USA) Russell K Statman, Esq. Executive Director Registrar Corp

Upload: registrar-corp

Post on 07-May-2015

477 views

Category:

Documents


2 download

DESCRIPTION

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.

TRANSCRIPT

Page 1: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

The U.S. FDA Food Safety Modernization Act

(For Exporters to the USA)

Russell K Statman, Esq.

Executive Director

Registrar Corp

Page 2: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

Food Safety Modernization Act

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

Page 3: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

FSMA Amends the Food, Drug & Cosmetic Act

Page 4: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

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

Page 5: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

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”

Page 6: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

New FSMA “User Fees” Effective October 1, 2011

May be Charged to: Importers Food Manufacturers “U.S. Agents”

Page 7: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

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

Page 8: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

United States Agent

Page 9: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

United States Agent

Page 10: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

Page 11: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

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)

Page 12: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

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”

Page 13: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

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

Page 14: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

Latest Developments

Page 15: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

Fee Rates

FDA Hourly Rate for Reinspection & Reconditioning:$221 per hour, domestic$289 per hour, if foreign travel is required

Page 16: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

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

Page 17: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

Reinspection Fees

Also include:TravelingPreparing any reportsAnalyzing any samplesExamining any labels if requiredPerforming other activities until the facility is in compliance

Page 18: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

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

Page 19: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

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

Page 20: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

Prior Notice

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

Page 21: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

FDA Food Safety Modernization Act

Record-keeping rules issued February, 2012

Page 22: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

Awaiting Regulations

Were due January 4, 2012Foreign supplier verification programPreventative controls for human and animal foodProduce SafetyThird Party Auditors

Page 23: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

Later this year…

October-December 2012Facility Registration and renewalNow Biennial (every even-numbered year)

Page 24: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

New FSMA User Fees

Fees may be charged to:Food manufacturersFood OwnerImporters“U.S. Agents”

Page 25: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

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”

Page 26: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

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.

Page 27: U.S. FDA Food Safety Modernization Act (FSMA) Seminar (English)

04/11/2023

Contact Us

144 Research Drive

Hampton, VA

USA 23666

P: +757-224-0177

F: +757-224-0179

E: [email protected]

W: www.registrarcorp.com