rules, obtain annually written assurance that the customer is manufacturing, processing, or preparing the
food in accordance with applicable
food safety requirements.
If the customer is not controlling the
hazard, but another entity further down
the distribution chain is controlling the
• Comply with the disclosure and
• Only sell the food to another entity
that agrees in writing that it will ei-
• Control the identified hazard, or
• Obtain a written assurance from
its customer that the customer
will make a similar disclosure and
obtain assurances. Written assur-
ances must include the effective
date, printed names and signa-
tures of authorized company offi-
cials, and the required assurances.
An evaluation of a foreign supplier
and performance of verification activities are not required if:
• A system that ensures control of a
hazard in the food at a subsequent
distribution step has been established
and implemented, and
• The implementation of that system is
Reevaluation of Foreign Supplier
Performance and Food Risk
Evaluations on the food and supplier
will be promptly reviewed whenever
new information becomes available that
may affect prior evaluations. At a mini-
mum, the food risk and foreign supplier
performance must be reevaluated every
3 years. In performing the reevaluation,
the previously identified factors relat-
ing to the foreign supplier and food are
considered. Appropriate corrective ac-
tions are to be taken in response to the
reevaluation, if necessary.
When considering new information,
determine whether the supplier verification activity needs changed or whether
to continue importing food from the
foreign supplier. All reevaluations and
corrective actions must be conducted by
a QI and documented.
The importer must approve their foreign suppliers on the basis of the evaluation of applicable FDA food safety
regulations and information relevant to
the foreign supplier’s compliance with
those regulations [ 21 C.F.R. Section
1.512 (c)(1)(i) or (c)(1)(iii)]. The importer
will import foods only from suppliers or
nonapproved suppliers, when necessary
and on a temporary basis, whose foods
are subjected to adequate verification
activities before being imported.
The following activities are to be
documented on designated records to
show the proper implementation of the
• Hazard Analysis of the food
• Foreign supplier evaluation
• Foreign supplier approval
• Determination of verification meth-
od and frequency
• Performance of verification activity
• Any necessary corrective actions
• Reevaluations of the FSVP either for
cause or routinely every 3 years
Records shall be kept for a minimum
of 2 years after the last use of the supplier, process, or procedure. Records
must be made available to FDA for
review upon request for inspection and
copying. The records, once obtained
by FDA, may be subject to Freedom of
Information Act requests.
It will take time to determine the effect of FSMA regulations on the safety
of the U.S. food supply. Even so, we
may not fully know the effect of each of
the individual FSMA rules. The Regulatory Impact Analyses for FSMA rules
will consider and analyze the reduction
in the number of illnesses and deaths
following implementation of the FSMA
regulations. The impact of each individual FSMA regulation will not be readily
determinable because sufficient data do
not exist to determine the effect one
regulation has on public health as compared with another. Therefore, FDA will
account for the public health benefits
of the FSVP regulation in the Preventive
Controls, Produce Safety, and other applicable food safety regulations. 3 n
Hank Cotney, M.Sc., is the director of Quality Assurance at Perdue Agribusiness.
2. Gould, L, et al. 2017. “Outbreaks of Disease Associated with Food Imported into the
United States, 1996–2014.” Emerg Infect Dis
4. U.S. Food and Drug Administration. 2015.
“Foreign Supplier Verification Programs for
Importers of Food for Humans and Animals,”
80 Fed Reg 74226.
5. U.S. Food and Drug Administration. January
2018. Foreign Supplier Verification Programs
for Importers of Food for Humans and Animals:
Guidance for Industry, Draft Guidance, 74.
Major Provisions of the FSVP Rule3
The primary actions defined in the FSVP rule require the importer to address the following in an
• FSVP activities are to be performed by qualified individuals.
• Identify known or reasonably foreseeable hazards in foods being imported.
• Evaluate the risk of the identified hazards using the Hazard Analysis method.
• Evaluate the foreign supplier’s performance.
• Use the evaluation of risk posed by the food, and the supplier’s performance, to approve the
supplier and determine appropriate verification activities.
• Conduct verification activities.
• Conduct corrective actions where appropriate.
• Reassess the effectiveness of the FSVP at appropriate intervals.
• Maintain records of FSVP activities as implemented.