FSVP: What Do
A Conversation with Sharon Mayl
The first major compliance date for importers covered
by the Foreign Supplier Verification Programs (FSVP)
rule arrived on May 30, 2017. FSVP is mandated by
the FDA Food Safety Modernization Act (FSMA). A
central tenet of that law is that the same preventive
food safety standards apply to food consumed in the
U.S., regardless of where the food is produced.
FSVP requires importers to verify that their foreign
suppliers of food for human and animal consumption
meet applicable FDA safety standards. More specifically, FSVP requires that importers verify that their
suppliers are producing food using processes and
procedures that offer the same level of public health
protection as the preventive controls (PC) requirements
in the preventive controls and current good manufacturing practices rules for human food and animal food
and produce safety FSMA rules, and that the food is
not adulterated and properly labeled with respect to
Sharon Mayl, Senior Advisor for Policy in the Office
of Foods and Veterinary Medicine at FDA, explains
what importers need to know when facing this May
compliance date and what lies ahead for FSVP implementation.
Q: When are the compliance dates for the
It is important to note the compliance dates for FSVP
are not based on the size of the importer. Instead, the
compliance dates are staggered based on the size of the
foreign supplier and the regulations that apply to the
foreign supplier. The first compliance date is eighteen
months after the FSVP final rule was published in the
Federal Register. This date gives importers sufficient
time to understand the rule and develop their FSVPs.
After that, importers generally have to comply six
months after their foreign supplier has to be in compliance with the PC or produce safety rules.
Q: Who must be in compliance with the FSVP re-
quirements by May 30, 2017?
U.S. importers subject to this first compliance date
have foreign suppliers that fall into one of three
categories: Foreign suppliers that will not be covered
by the PC or produce safety rules; Foreign suppliers
subject to the PC for Human Food rule and are not
“small businesses,” “qualified facilities” (certain very
small businesses) or subject to the Pasteurized Milk
Ordinance; or Foreign suppliers subject to the current
good manufacturing practices (CGMP) requirements in
the PC for Animal Food rule, and are not “small businesses” or “qualified facilities”.
Q: What do importers have to verify on
May 30, 2017?
Importers covered by the FSVP rule will have to verify
that their suppliers meet applicable FDA food safety
requirements, including that the food is not adulterated
or misbranded with respect to allergens.
The largest foreign suppliers subject to the PC for
Human Food rule had to be in compliance in Septem-
ber 2016 with both the PC provisions and the CGMP
requirements of that rule, but the largest suppliers sub-
ject to the PC for Animal Food rule only had to be in
compliance with the CGMP requirements by that date.
Therefore, importers of foods from those facilities will
only need to consider those provisions of the PC rules
that their suppliers have had to come in compliance
with by May 30, as well as verify that the food is not
adulterated or misbranded with respect to allergens.
Importers will need to have a program that allows
them to demonstrate that their foreign suppliers
are producing food in a manner that provides the
same level of public health protection as the PC
or produce rules. Importers will have additional
time to develop and implement FSVPs for foods
from smaller suppliers that are considered qualified
facilities or small businesses under the PC rules, as
well for food subject to the produce safety rule.
Q: When the first compliance dates arrived in
September 2016 for the preventive controls rules,
FDA indicated that it would focus on education,
training, and technical assistance. Is that also
true for this FSVP compliance date?
Yes, we have done a lot of outreach already to help
importers understand the regulations and what they
have to do. However, we understand that this is
new to a lot of importers, so our approach will be
to educate while we regulate to create a culture of
compliance. Importers can expect interactive FDA
inspections with opportunities to explain how their
programs meet our requirements and how they will
take corrective actions if we observe deficiencies.
Good communication is key. Our initial enforcement priorities will be, as they are now, on food
safety problems that pose an imminent public health
risk. But the FDA’s mandate is to protect public
health and, when appropriate, the agency will act
Q: Will FSVP change the admission process?
All foods regulated by the FDA will see changes
to the entry process as of May 30, 2017. When
food is offered for entry into the United States, the
Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system will require
the filer to enter at least one additional code as part
of the required data elements. An FSVP importer
subject to the May 30 compliance date should use
the entity role code “FSV,” indicating the entry
is subject to the FSVP regulation. This will then
prompt the ACE system to ask for the importer’s
name, email address, and unique facility identifier (UFI) recognized as acceptable by FDA. We
recently issued guidance formally recognizing the
Data Universal Numbering System (DUNS) number
as an acceptable UFI for FSVP.
Conversely, if the food entry line is exempt from
the requirements of FSVP, or not yet subject to the
rule because it has a later compliance date, the filer
should use one of two Affirmation of Compliance
codes, either “FSX” (designating that the food is
exempt from FSVP or that compliance with FSVP
is not yet required) or “RNE” (designating, more
specifically, that the food is exempt from FSVP
because it will be used for research or evaluation
in accordance with 21 CFR 1.501(c) of the FSVP
regulation). If one of these codes is not transmitted
for an imported food product under FDA jurisdiction, the entry line will be rejected.
We have heard that there is some concern within
the importing community that not everyone will be
able to obtain a DUNS number in time for the first
compliance date on May 30. While we expect all
FSVP importers to provide their UFI starting on
the applicable compliance date, because this is a
new rule, we have provided a temporary solution. For
a limited time, importers can submit the value “UNK”
(to represent “unknown”) in the entry data field where
the DUNS number would have been provided for the
FSVP importer. This will give importers extra time
to obtain their DUNS numbers and will provide us
with a list of FSVP importers whom we can contact to
ensure they understand and are taking the necessary
steps to meet the FSVP requirements. But, remember,
the submission of the “UNK” option is temporary.
Therefore, FSVP importers should work now to ensure
they have accurate and complete entry data (including
their DUNS numbers) and understand the process for
filing to avoid any future delays in the entry of their
It is important to note that while importers will be required to provide their importer identification information through the ACE system, we will not be enforcing
overall compliance with this rule on a shipment-by-shipment basis at the port of entry. Rather, our general
approach to enforcing compliance will be to inspect
U.S. importers and review their records to make sure
they are in compliance.
Q: What can importers expect when an investigator
reviews their FSVPs?
Remember that, unlike traditional facility inspections,
FSVP inspections are based on the review of records,
rather than observations of food production. While
most of the FSVP inspections will be at the importer’s
place of business, we are also going to request that
some importers provide FSVP records to FDA electronically, or through other means that delivers the
records promptly, as part of a pilot program. In either
case, the investigator will ask to view the importer’s
FSVP records to determine if there are deficiencies. In
most cases, if any deficiencies are found, the importer
will be provided an opportunity to correct them. Our
focus right now is on supporting compliance, except
for problems that pose a danger to health or reflect
intentional disregard for legal responsibilities.
I also want to emphasize that we are investing significant resources in training FDA personnel on how
to conduct these inspections. Importers can expect an
approach that is interactive, and by that I mean that
our investigators will be asking questions about what
they see and there will be the opportunity for a real
dialogue. We encourage importers to keep the lines of
communication open with FDA if problems are found.
If a corrective action is needed, the importer should
communicate clearly what actions will be taken and by
what date the corrections will be completed. If problems arise in meeting deadlines, the importer should
let us know.
Q: I already audit my supplier. Can I use that audit
as a verification activity?
There are many different types of verification activities that can be used to meet the requirements in
the rule. The rule mentions review of the supplier’s
relevant food safety records, sampling and testing,
and onsite auditing as examples of verification activities that may be appropriate, either individually or in
combination. Which activity importers choose should
be based on their evaluation of the risk of the food and
their supplier’s performance.