U.S. of a food produced in a foreign
facility that has refused to allow U.S.
inspection. It will, however, be interesting to see how the FDA manages
those foreign firms that do not explicitly refuse inspection, just stall it.
The Foreign Supplier Verification
Program (FSVP) requires importers
to conduct foreign supplier verification activities to prove that imported
food is not adulterated and that it was
produced in compliance with the
FDA’s preventive controls requirements and safety standards where applicable. FSVP will apply to all
imported food unless there is a specific exemption. Importers must verify that the imported food is
produced in compliance with Hazard
Analysis and Critical Control Points
(HACCP) regulations and/or Good
Agricultural Practices as specified in
Section 419 as appropriate, and that
it is not adulterated or misbranded
under Section 403(w) (which declares a food containing an undeclared allergen to be misbranded).
Before the passage of FSMA, the
FDA opened additional offices in key
international locations and materially
increased the number of foreign inspections. FSMA directs the agency to
inspect at least 600 foreign food facilities within the first year and then double those inspections every year for
the next five. If you do the math, this
means that in six years, FDA will be
conducting 19,200 foreign inspections annually. According to the
FDA’s website, “FDA focuses its domestic and foreign food inspections
on high-risk food establishments.”
High-risk food establishments are
growers/harvesters, manufacturers/
processors, packers, repackers and
holders of those foods that present
hazards that FDA believes, based on
scientific evidence, may have a high
potential to cause harm. FDA’s current list of high-risk items can be
found on page 20.
FDA will continue to conduct elec-
tronic risk-based screening of all food shipments before they arrive in
the country and conduct further analyses at the port of entry when
warranted. FDA’s methods are becoming more sophisticated and in-
clude PREDICT, an electronic system that helps target higher-risk ship-
ments for examination. It will also expedite the clearance of lower-risk
cargo, provided accurate and complete data is furnished by importers.
