resource to help you with the responsibilities. It is a requirement of the FSVP rule
that certain activities must be carried out only by a QI.
Step 3: Implement QI responsibilities
cal requirements of the FSVP rule
without the help of a QI. If you can
afford it, you may hire a full-time QI.
Alternatively, you may seek an external
Are you the U.S. owner or consignee of an article of food that is being offered for import into
the United States? Or, if there is no U.S. owner or consignee of an article of food at the time of
U.S. entry, are you the U.S. agent or representative of the foreign owner or consignee at the
time of entry?
Do you only import these foods? Includes fish and fishery products (in compliance with Part
123) or certain ingredients for use in fish and fishery products in compliance with Part 123,
juice (in compliance with Part 120) or certain ingredients for use in juice products in compliance with Part 123, food for research or evaluation, certain alcoholic beverages or certain
ingredients for use in alcoholic beverages, certain meat, poultry, and egg products regulated
by the U.S. Department of Agriculture, food imported for personal consumption, food that is
transshipped, food that is imported for processing and export, and U.S. food that is exported
and returned without further manufacturing/processing in a foreign country.
Do you import LACF in compliance with 21 C.F.R. Part 113?
Are you a receiving facility in compliance with requirements in the Preventive Controls rules
related to implementation of preventive controls for the hazards in the food or supply chain
programs, or are you not required to implement a preventive control under those rules in
certain specified circumstances?
Do you import dietary supplements subject to certain dietary supplement Current Good Manufacturing Practices requirements in 21 C.F.R. Part 111?
Are you a very small importer? (See definition in 21 C.F.R. 1.500 and 1.512.)
Do you import food from certain small suppliers (i.e., qualified facilities under the Preventive
Controls rules, certain farms that are not covered farms under the Produce Safety rule, and
certain small egg producers)?
Do you import certain food from a country with an officially recognized or equivalent food
You are subject to the FSVP.
The FSVP does not apply to you.
The FSVP does NOT apply to these foods.
You do not need an FSVP with respect to
microbiological hazards for that food. Instead,
you must verify and document that the food
was produced in accordance with 21 C.F.R. Part
113. With respect to all matters that are not
controlled by Part 113, you must have an FSVP.
You are deemed in compliance with most
aspects of the FSVP, except the requirement
for importer identification at entry.
You are subject to modified FSVP requirements for those dietary supplements subject to
separate, preexisting Current Good Manufacturing Practices requirements for dietary
You are subject to modified FSVP requirements. An example of modified requirements
for certain importers is that they would not
have to conduct Hazard Analyses and would
be able to verify their foreign suppliers by
obtaining written assurances of compliance.
You are subject to modified FSVP requirements
for food from those suppliers.
You are subject to modified FSVP requirements for food from those suppliers. (Includes
determining that the supplier is in compliance
with U.S. safety regulations or relevant laws in
country deemed equivalent.)
Figure 1. Am I Subject to the FSVP?