On November 13, 2015, the FDA
finalized its rule on Foreign Supplier Verification Programs (FSVP) for
Importers of Food for Humans and Animals.
The
rule is scheduled to be published in the Federal Registeron
November 27, 2015. The pre-publication version of the rule is available here. The
linchpin of the rule is the requirement that importers implement a FSVP to
verify that their foreign suppliers are producing food in a manner that
provides the same level of public health protection as the preventive controls
or produce safety regulations, and to ensure that the supplier’s food is not
adulterated and is not misbranded with respect to allergen labeling.
Importers covered by the rule
will need to:
·
Determine known or reasonably
foreseeable hazards with each food. These can include biological
hazards such as parasites, chemical hazards such a pesticide residue, and/or
physical hazards such as glass. The importer’s analysis must assess the
probability of these hazards and that the severity of the illness or injury
that could potentially occur by evaluating factors such as how the food is
harvested or manufactured, how the food is packaged, how it is transported,
etc. The importer can also rely on another entity to conduct this hazard
analysis as long as the importer reviews and assesses all relevant
documentation related to the analysis.
·
Evaluate the risk posed by a
food, based on the hazard analysis, and the foreign supplier’s performance.
Factors that importer’s must consider in the evaluation can include the foreign
supplier’s procedures, processes, and practices related to food safety, and any
information that FDA may have regarding the foreign supplier’s compliance. The
importer can also rely on another entity to perform the risk evaluation under
certain circumstances.
·
Use that evaluation to approve
suppliers and determine appropriate supplier verification activities.
Based upon the evaluation of risk conducted, the importer must establish and
follow written procedures to ensure that it only imports from approved foreign
suppliers. Appropriate supplier verification activities may include annual
on-site audits of the supplier’s facility, sampling and testing, or a review of
the supplier’s relevant food safety records. The importer can also rely on
another entity to determine and perform appropriate supplier verification
activities under certain circumstances.
·
Conduct corrective actions. If
something goes wrong and an importer determines that its foreign supplier has
not used safe processes and procedures, the importer must take immediate
corrective action. The appropriate action will depend on the circumstances, but
can include discontinuing use of the foreign supplier until the cause of
noncompliance, adulteration or misbranding has been adequately addressed.
Some key points about the FSVP
rule are:
·
Very small importers are
subject to modified requirements. The definition of very small importer is an
importer with a sales ceiling of $1 million for human food and $2.5 million for
animal food.
·
Importers of certain small
foreign suppliers are also subject to modified requirements, e.g. farms that
are not covered farms under the produce safety rule because they average $25,000
or less in annual produce sales.
·
Certain foods are not covered
by FSVP, including (1) juice and fish that complies with FDA’s Hazard Analysis
and Critical Control Point (HACCP) regulations; (2) food for research or
evaluation; (3) food for personal consumption; (4) alcoholic beverages; (5)
food that is imported for processes and future export; (6) low-acid canned
foods; and (7) certain meat, poultry, and egg products that are regulated by
the U.S. Department of Agriculture at the time of import.
·
If an importer is subject to
FSVP rules, the general compliance deadline will be within 18 months of the
anticipated November 27, 2015 publication date.
In light of this new rule, it
is important for companies to determine whether they are subject to FSVP
requirements, and, if so, to begin taking steps to ensure compliance.
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