Foreign Supplier Verification

Presented By:
Stephanie Lopez
Director, Food Safety Education
AIB International

WHAT
WHY
WHO
WHEN
HOW

WHAT IS FOREIGN SUPPLIER VERIFICATION?
Food Safety Modernization Act
• Section 301
Risk-Based Verification
• Imported food is not adulterated or misbranded
• Imported foods meet US Standards

WHY IS FOREIGN SUPPLIER VERIFICATION
NEEDED?
Imports from more than 150 countries
13% of US Diet is Imported Foods
FDA only inspects 1%

WHY IS FOREIGN SUPPLIER VERIFICATION
NEEDED?
Melamine - Wheat / Milk – China (2007 / 2008)
Salmonella – Papayas – Mexico (July 2011)
Salmonella – Pine Nuts – Turkey (Nov 2011)
Undeclared Yellow #6 – Dates – China (Oct 2011)
C. Botulinum – Stuffed Olives – Italy (Nov 2011)
Listeria Mono – Cheese – Canada (Dec 2011)

WHY IS FOREIGN SUPPLIER VERIFICATION
NEEDED?
Import Alert List by Country (1/6/2012)
• China – 69
• Mexico – 64
• Canada – 61
• Thailand – 46
• Hong Kong – 45
• Taiwan – 44
• India – 41
• Japan – 39
• United Kingdom – 39
• Germany - 33
Automatic Ban on Specific Products
DWPE: Detention Without Physical
Examination

WHO IS RESPONSIBLE FOR FOREIGN SUPPLIER
VERIFICATION?
FDA
• Issue Guidance for Developing Program
• Publish Regulation Regarding Content of Program
Importer
• Verify that the food imported is as safe as food
produced within the US
• Verify that the supplier is complying with Food,
Drug, and Cosmetic Act

WHO IS RESPONSIBLE FOR FOREIGN SUPPLIER
VERIFICATION?
Who are Importers?
• US Owner of the Food at Time of Entry
or
• Consignee of the Food at Time of Entry
or
• US Representative of the Foreign Owner
• NOT THE BROKER

WHO IS RESPONSIBLE FOR FOREIGN SUPPLIER
VERIFICATION?
Exceptions
• Facilities that fall under:
Seafood HACCP
Juice HACCP
Low Acid Canning (micro exemption only)
• Small quantities:
Personal Use
R&D Use (not distributed to the public)

WHEN DOES FOREIGN SUPPLIER VERIFICATION
NEED TO BE IN PLACE?
Jan 4, 2012 Postponed to Jul 2012
FDA Guidance Due
FDA Regulation Due
Presented with Hazard Analysis and
Preventive Controls Guidance
4
Jan 4, 2013 Postponed?
Foreign Supplier Verification Effective Date

HOW IS FOREIGN SUPPLIER VERIFICATION
ACCOMPLISHED?
FSMA: Activities MAY include
• Monitoring records for shipments
• Lot-by-lot certification of compliance
• Annual on-site inspections
• Check Hazard Analysis/ Preventive Controls Program
• Sampling and testing of product

HOW IS FOREIGN SUPPLIER VERIFICATION
ACCOMPLISHED?
Ensure foreign supplier registers with FDA
biennially (every 2 years)
Record Retention
• Records of Verification
• At Least 2 Years

HOW IS FOREIGN SUPPLIER VERIFICATION ACCOMPLISHED?
Supplier
Verification
Foreign Supplier
Verification
Specifications X X
Letters of Guarantee X X
Certificates of Analysis X X
Product Testing X X
Historical Performance X X
Third Party Audit Reports X X
Copy of HACCP / HARPC Plan X X
Insurance X X
Food Defense, Training, GMP’s,
Traceability, etc…
Country of Origin X X
Kosher, Organic, GMO, Halal X X
X
X

WHAT IS THE QUALIFIED IMPORTER PROGRAM?
HOW DOES IT RELATE TO FSVP?
User-fee funded program to expedite entry
• Section 302, FSMA
• Supplier must be certified by an accredited third
party (process not yet defined)
• Guidance due by July 4, 2012
In addition to Foreign Supplier Verification

WHAT ARE IMPORT CERTIFICATIONS?
HOW DOES IT RELATE TO FSVP?
FDA has right to mandate certificates to
accompany imported food
• Section 303, FSMA
• Certificate = Assurance of Compliance with FDA
Regulations
May include COA’s, chain of custody
Based on risk due to food type, region
Details and time line not yet defined
In addition to Foreign Supplier Verification

Global Food Supply
The US importer is responsible for protecting
the US consumer from the foreign supplier
• Food Safety
• Adulteration
• Misbranding
• Regulatory compliance (Registration, RFR)
Reduce Outbreaks and Recalls due to Imports
Risk-Based Prevention

More Information
FSMA Updates www.FDA.gov
AIB Knowledge Center www.aibonline.org
Stephanie Lopez
slopez@aibonline.org