that exposure to a hazard controlled by the foreign supplier will result in serious adverse health consequences or death to humans or animals (a SAHCODHA hazard).
However, the importer can also choose other means of verification, provided the
alternate choice will ensure that the foreign supplier is producing the food in accordance with applicable U.S. safety standards. An importer can also rely on another
entity to determine and perform appropriate supplier verification activities, so long
as the importer reviews and assesses the relevant documentation.
Taking appropriate corrective action by importers is the last piece of the puzzle
in meeting the FSVP requirements. At times, an importer’s verification activities
may provide evidence that a foreign supplier has not provided the same level of
public health protection as required under the Produce Safety and Preventive Controls rules. This should promptly trigger corrective actions at the importer’s end.
The appropriate corrective measure will depend on the circumstances and may include
discontinuing the use of the foreign supplier.
The FSVP rule requires importers to provide the name, email address, and unique
facility identifier (UFI) for each line entry of
food product offered for importation into the
United States. FDA has recognized the data
universal numbering system (DUNS) number
as an acceptable UFI for the FSVP. If the
importer is temporarily unable to obtain the
DUNS number, FDA intends to temporarily
allow filers to transmit the value “UNK” (“
unknown”) in the UFI field. This option began
May 30, 2017, so that food offered for import
could be processed through the Customs and Border Patrol automated commercial
environment system, even if the importer has not yet provided a DUNS number.
Are There Exemptions from FSVP Rules?
Importers of the following categories of food products do not have to comply
with the FSVP rule:
• Juice, fish, and fishery products subject to and in compliance with FDA’s Hazard
Analysis and Critical Control Points (HACCP) regulations for those products,
and certain ingredients for use in juice and fish and fishery products subject to
the HACCP regulations
• Food for research or evaluation
• Food for personal consumption
• Alcoholic beverages and certain ingredients for use in alcoholic beverages
• Food that is imported for processing and future export
• Low-acid canned foods (LACF), such as canned vegetables, but only with re-
spect to microbiological hazards covered by other regulations, as well as certain
ingredients for use in LACF products (but only with respect to microbiological
• Certain meat, poultry, and egg products regulated by the U.S. Department of
Agriculture (USDA) at the time of importation
Who Is Eligible for Modified FSVP Requirements?
In certain cases, importers need not comply with all the FSVP requirements. The
criteria for modified FSVP requirements are listed below.
Dietary supplement importers: Importers complying with the requirements of 21
C.F.R. Part 111 (Current Good Manufacturing Practices) regulation will be required
to comply with the modified requirements. Importers of other dietary supplements
would be required to comply with the
standard FSVP requirements (except the
Hazard Analysis requirement).
Very small importers and importers of
food from certain small suppliers: The defi-
nition of “very small importer” is an-
nual sales of $1 million for human food
and $2.5 million for animal food (aver-
aged over a 3-year period) combined
with the U.S. market value of food that
is imported, manufactured, processed,
packed, or held without sale (e.g., im-
ported for a fee). In this case, importers
would not have to conduct Hazard
Analyses and would be able to verify
their foreign suppliers by obtaining writ-
ten assurances from their suppliers.
Importers of certain small foreign suppliers are subject to modified FSVP requirements: Those small suppliers are:
• Facilities subject to modified require-
ments under the Preventive Controls
rules because they are qualified facili-
• Farms that are not covered farms
under the Produce Safety rule be-
cause they average $25,000 or less in
annual produce sales or because they
meet requirements for a qualified
• Shell egg producers with fewer than
3,000 laying hens
• Products from countries whose food
safety system has been recognized as
comparable or determined to be the
equivalent of the U.S. system (e.g.,
Canada, New Zealand, Australia)
Please verify the applicability of the
FSVP rule to you using the flowchart in
How to Develop and
Implement a Robust FSVP?
Although FDA had been working on
the FSVP rule for quite some time, the
requirements caught many an importer
off guard, specifically, those pertaining
to developing food safety plans to con-
trol the safety of products they import.
Many importers simply do not have the
technical expertise or resources.
Traditional FDA inspections are pro-
duction-centric. FSVP inspections, on
the other hand, will be based on review
“It is also likely
importers are also
The Foreign Supplier Verification Program