Baking & Snack - May 2018 - 26

FSMA UPDATE

To better understand a
foreign supplier's level
of compliance, FSVP
importers can schedule
an AIB inspection.
AIB International

used to submit international trade data. Food items are
then flagged for FDA and require identification including the FSVP importer's name, address and Unique
Facility Identifier. FDA deemed the Data Universal
Numbering System (DUNS) acceptable last year.
This is where confusion occurs.
Some companies are unsure who FSVP importers are
and what they do; others are putting down the standard
importer of record instead of the FSVP importer. These
situations can be problematic because not only are FSVP
importers key at the point of entry, but they are also the
central characters of the regulation.
Cornelius Hugo, food safety professional, AIB
International, said there are three qualifications for
FSVP importers. First, the importer must be a person.
Companies importing must choose someone for this
position. Second, that individual must reside in the US
inside the FDA's jurisdiction.
Lastly, the FSVP importer will be the person responsible
for bringing the food into the US. It could be a processing
facility's employee or a hired broker. Or it could be an independent importer that resells the products or the agent
of a foreign firm residing in the US. Whatever the case, the
FSVP importer must own that product at the time of entry,
or have agreed in writing to purchase the food at such time.
"The best way to define the FSVP importer is to follow the
money trail," Mr. Hugo said. "Whoever puts up the money
really is the product importer."
Russell Statman, executive director of FDA compliance consultant company Registrar Corp, said an exception when declaring an FSVP importer is when more than
one person satisfies the requirements. For example, if an
American company is the FSVP importer - meaning it
bought the food and is importing it - and another company has purchased the food from that importer before
the food's entry, both businesses could qualify as the FSVP
importer. "In that case, FDA takes no position on which
company has to be put into the system," Mr. Statman said.
"There's only room for one in the field, and it's up to the
businesses involved to allocate that among themselves."
But the importer's role in FSVP doesn't stop with the
name being put into ACE/ITDS. FDA states that an

26 Baking & Snack May 2018 / www.bakingandsnack.com

FSVP importer, whether part of a manufacturing company or an independent importer, is responsible for creating an FSVP plan and keeping its foreign supplier in
compliance with it. This qualified auditor's door is the
one the FDA will come knocking on.

"The best way to define
the FSVP importer is to
follow the money trail."
Cornelius Hugo, AIB International
"Thousands and thousands of importers are now
scrambling because they've never had to deal with
sanitation and food safety issues" Mr. Hugo said. "They
know their product really well, but they don't know
about applicable food sanitation and safety rules and
regulations. They're saying, 'What do I know about FDA
inspections? What do I know about import red alerts?
What is Part 117?' "
Some importers don't even realize creating an FSVP
plan is their responsibility. Mr. Hugo recalled a frantic
call AIB received last year from a client who didn't understand his role as the FSVP importer and needed help
getting in compliance quickly. The FDA had contacted
him earlier that day and asked to see his FSVP program.
His response was, "I don't know what you're talking
about. I'm just a salesman." He was supposed to have a
plan in place months before.
The new role not only requires knowledge of compliance management, but it also takes up more time. "It
changes the way trade is done," Mr. Statman said. "A lot
of companies won't want the responsibility of making
sure the food is safe. For them, if they actually don't buy
any product until it is in the US and let somebody else
import it, then they're okay."

Record keeping
Unlike other regulations, FDA doesn't review FSVP
compliance by first physically going to the importer's

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Baking & Snack - May 2018

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