FSMA Foreign Supplier Verification
Rule: Top 5 Points for Manufacturers
By Randy Fields, Chairman & CEO of Park City Group and CEO of Reposi Trak
It’s a new world for any company manufacturing food products for sale in the United States.
As part of the Food Safety Modernization
Act (FSMA), all importers of foreign
food must maintain a Foreign Supplier
Verification Program (FSVP) that ensures
each imported item is produced in
compliance with processes that meet the
FDA’s standards for preventive controls
Companies importing food products
must anticipate hazards associated
with the imported food and evaluate
the risk posed by the food based on the
hazard analysis. The supplier’s record of
compliance is also considered along with
a renewed analysis every three years or
when new information comes to light. In
general, these companies must maintain
the integrity of their extended supply chain.
Here’s what you need to know:
1. There are New Rules
Defining Who is an Importer
Under FSMA’s Foreign
Supplier Verification Rule
Under FSMA, the importer is the U.S.
owner or consignee of an article of food
that is delivered to the U.S. from any other
country at the time of U.S. entry. And it’s
likely that there may be more than one
entity considered the importer. If you are
still unsure as to whether you are the
importer, try answering the questions
below. If you answer “me” to any of them,
you might want to have your food safety
team confirm your status as the importer
with your foreign suppliers:
• Who is in the best position to assure
the foreign supplier produces food that
meets U.S. standards and is as safe as
food produced by a U.S. supplier?
• Who is most likely to have knowledge of
food safety practices?
• Who controls the supply chain of an
• Who controls the finances of the
imported food (owner or consignee)?
• Who controls the goods? Whose truck
picks it up or in whose distribution
center is the product stored?
• Who can best ensure that supplier
verification activities are conducted for
each food imported into the U.S.?
2. It is Critical to Know What
Comprises a FSVP Program
The new regulation puts the burden of
proof on importers since it requires them
to establish and follow written procedures
for verifying foreign suppliers and
correcting any violations of FDA standards.
If you are considered the importer, you
must have a separate FSVP program in
place for each food product and each
foreign supplier, even if the same food
is obtained from a number of suppliers.
Proper documentation is essential to
maintaining access to U.S. food markets
since this will be the primary means by
which FDA will establish compliance with
FSVP. If you are not the importer, it might
make sense to ensure you have copies of
what your importer says he or she has on
file. (Hint: it’s a good idea to trust, but verify
in this situation.)
3. You Will Need to Meet the
Any record requested by the FDA must
be available within 24 hours and could
go two years back. If you don’t have an
automated system, it’s time to consider
one, as it’s really the only way to manage
the range of documents required by
FSVP across a retailer’s or wholesaler’s
vast supplier base. (Verification includes
on-site audits, sampling/testing, records,
certificates of conformance and continuing
4. The CEO’s Responsibility
Under FSVP has Expanded
Senior executives in the extended
retail food supply chain are personally
responsible not only for their company’s
compliance with FSVP, but also for verifying
the compliance of the company’s upstream
5. Now is the Time to
Implementing a new system with
suppliers will take time. It is your
responsibility to ensure you and your
suppliers are in compliance by the deadline.
FSVP compliance goes into effect for most
companies at the end of May 2017.
While most like to think that providing
safe food is just the right thing to do,
there’s an obvious competitive advantage
for those foreign suppliers who are able
to meet the requirements, thereby
making themselves more desirable in
the supply chain. So it’s critical to
understand not only what the importer
should be doing to comply with FSVP, but
also what the supplier can do in advance
to help the importer meet its obligations
under the law.
As part of the Food Safety Modernization Act, all importers of foreign food must maintain
a Foreign Supplier Verification Program that ensures each imported item is produced in
compliance with processes that meet the FDA’s standards for preventive controls and safety.