ucts manufactured in the U.S. and will not pose any public health issues in the U.S.
Your foreign suppliers may not be knowledgeable about the applicable Preventive
Controls rules (human food or animal food), Produce Safety rule, or other relevant
product-specific regulations. It is your responsibility to provide the relevant information to them.
You may request the foreign supplier or foreign manufacturer to assist you in
preparing your FSVP by providing relevant information regarding the potential hazards and the control or mitigation strategies related to their products.
It is certainly a difficult task, at least for small importers, to meet such techni-
of records, according to Sharon Mayl,
senior adviser for policy in the Office
of Foods and Veterinary Medicine at
FDA. Further, while most of the FSVP
inspections will be at the importer’s
place of business, FDA may also request
importers to provide FSVP records
electronically, or by other means, to
get them promptly. During the initial
stages of FSVP implementation, FDA
inspectors may review records and pro-
vide importers opportunities to correct
them to support compliance. However,
this approach will not be applicable to
problems that pose a danger to health
or reflect intentional disregard for legal
responsibilities, according to Mayl.
A six-step approach to implementing
an effective FSVP is shown below.
Step 1: Determine type of food/food categories to be included in the FSVP
The first step is to determine what
food or food categories are to be included in the FSVP. FSVP requirements are
risk based and depend on the type of
food, type of hazard, and performance
of suppliers. Per the FSVP rule, an importer is required to prepare an FSVP
for each imported food or food category
from each facility and each country.
This is because the potential hazards
requiring preventive controls may be
specific to the type of food or food category from each facility and from each
country. It may be possible to combine
products and include them all under
one FSVP, provided the hazards are the
same or similar. However, you are still
expected to prepare different FSVPs for
the various facilities and various countries from which you import these products. If this is not clearly understood,
you may get into issues with FDA.
Step 2: Assign responsibilities
As an importer, you must clearly
understand the roles and responsibilities of the various entities, such as the
importer, foreign supplier, and qualified
individual (QI). Assigning responsibility does not absolve you from ensuring
that the food you import is equivalent
with respect to the safety of the prod-