Voluntary Qualified Importer Program under FSMA

– Today we’d like to talk
about the Voluntary Qualified
Importer Program, or VQIP, under FSMA.
When Congress passed
FSMA, they instructed FDA
to create a program that’s different
than their ordinary
approach to food safety.
Ordinarily, FDA is gonna
monitor, control, sample, test,
or, in the case of FSMA,
they’re gonna require importers
to put in all sorts of
systems in order to ensure
their suppliers are in
compliance with the law.
This program is a voluntary
program and it’s supposed to be
similar in a food safety
context to customs program
with respect to terrorism,
which is called CTPAT.
In that program, and similar with VQIP,
the importer brings to the agency
information that shows that
they are best in class,
they’re best in class on food safety,
they’re best in class ensuring
that their foreign suppliers
understand and are
complying with requirements
to ensure food safety, and as a result,
they should get some benefit
when they import product
within those kinds of supply chains.
And so the FDA has
already begun the process
of implementing and
developing a draft guidance
for importers who are
interested in participating
in this voluntary program.
So under the statute and
FDA’s plan for implementation,
what would you need to do in order
to qualify under the VQIP program?
Well to begin with, you’d
have to have a quality
assurance program in order to show the FDA
that you understand the
food safety requirements
and you’ve built it into a
system that ensures that every
time you bring product in
through a certain supply chain,
that it’s going to be,
the food will be safe.
Secondly, the facilities
that are participating
in the VQIP program must
have a facility certification
under FDA’s new and not-yet-created
accredited third-party certification rule,
that will take some time to implement.
You would need to have three
or more years of experience
in the importing food with very
little problems historically
and of course, you’d
need to be in compliance
with FSVP and the other applicable
food safety risk related regulations.
Now, for any voluntary program
to work, there must be some
benefit or the trade will not participate.
So Congress recommended
and FDA has started
to put into place the kinds of benefits
that a participant in VQIP would obtain
by being a part of the program.
For instance, when your food
is imported to the United States,
you would enjoy some expedited
entry review and release,
which is actually valuable
what would otherwise
be considered higher-risk foods.
If there’s an examination
that is conducted,
usually it’s only for cause,
that is the FDA has some
reason to believe that
that particular shipment
might be a problem, that
it usually would not enjoy,
would not have randomized
examinations conducted.
If FDA does sample, then
that sampling can occur
at the importer’s presence,
even if that presence,
that facility, is more than 50 miles away,
which is sort of a general rule
that some of the ports use,
they want the food to
stay close to the port.
If you’re in VQIP, then that
generalized rule wouldn’t apply
to you, you’d be able to
put it in your facility.
If some laboratory review is conducted
or some samples are
collected, then the lab work,
the analysis and the review
of that would be expedited
in order to speed the process up.
You would have access to an FDA help desk
in order to discuss the
status of expedited entries
in order to try to help move
those shipments through the process.
And then because you’re a
voluntary member of VQIP,
your name would be on a public database,
if you would like that,
because what that would do
is then give you value
with respect to your brand
that you’re recognized by the FDA
as a best in class food importer.
So where is FDA in the process
and who will this actually help?
In June 2015, FDA issued
its draft guidance
to implement VQIP and FDA’s
hoping they’ll receive
the first applications
from importing members
in January 2018, and for
those members to begin
enjoying the benefits under
the program by October 2018.
That seems like a long way off,
but it’s actually quite aggressive.
But who’s really gonna be helped by it?
In our view, those companies
that will be most helped
will be those companies that
bring a lot of shipments in,
so these are large companies,
that therefore often have
a high examination count
because they have so many shipments,
this would reduce that count
and help them expedite their product.
Other groups would be those
importers of perishable products
because of the expedited
nature of the entry.
So there’s less delay on
fresh fish or fresh produce.
As long as the importer can show
that their suppliers are compliant
with the food safety
program, then they’d be able
to bring the product and have
less delays at the border.
And I believe that another
great beneficiary really
is the consumer because of the reduction
in cost of food because of the reduction
in cost of delay, that’s unnecessary,
that’s happening at the
border today in these areas.
Thank you for spending a few minutes
with us here at fdaimports.com.
We remain committed to helping
the industry and our clients
understand and comply
with these regulations
as they’re implemented by the FDA.

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