Food, Drug & Device Law Alert - FDA To Delay Enforcement Of
Certain Provisions Of Food Safety Modernization Act
Companies in the food industry can breathe a sigh of relief when
it comes to complying with the Food Safety Modernization Act
(FSMA). In light of the then-impending (and now passed) July 3
effective date for certain provisions of the FSMA, the FDA notified
certain food industry trade associations that it will delay
enforcement of these provisions until after it has adopted final
regulations to implement them.
More specifically, with respect to sections 103 and 301 of the
FSMA, FDA wrote that it will be issuing proposed rules implementing
those sections and "will expect to enforce compliance with
these new FSMA requirements in timeframes that will be described in
the final rules." Given that FDA has not issued proposed
rules, and there will be a public comment period before any final
rules are adopted, it appears enforcement will be delayed for some
As noted in a prior Alert, Section 103 relates to hazard
analysis and risk-based process controls (HARBPC) and requires a
food facility to "evaluate the hazards that could affect food
manufactured, processed, packed, or held" by the facility, to
"identify and implement preventive controls to significantly
minimize or prevent the occurrence of such hazards," to
"monitor the performance of those controls," and to
"maintain records of this monitoring as a matter of routine
practice." Section 103 expressly requires the facility to
prepare a written plan analyzing the potential hazards and
identifying the preventive controls adopted to address them. It
also requires the facility to re-analyze potential hazards whenever
there is a significant change in operations or every three years at
a minimum. Finally, Section 103 requires the facility to maintain
records of at least the following: (1) monitoring of the preventive
controls implemented; (2) instances of non-conformance material to
food safety; (3) testing and other appropriate means of
verification; (4) instances when corrective actions were
implemented; and, (5) the efficacy of preventive controls and
corrective actions. The facility must retain the records for at
least two years.
Section 301, titled "Foreign Supplier Verification
Program," requires each importer of food into the US to
"perform risk-based foreign supplier verification activities
for the purpose of verifying that the food imported" complies
with US law. Section 301 requires the FDA to issue guidance and
promulgate regulations that require an importer's verification
program to "provide the same level of public health protection
as those required" under Section 103 (discussed above) and
another section of the FSMA. It also identifies potential
verification activities that can be required, including (1)
monitoring records for shipments, (2) lot-by-lot certification of
compliance, (3) annual on-site inspections, (4) checking the
foreign supplier's HARBPC plan, and (5) periodically testing
and sampling shipments. Again, the FSMA requires that importers
maintain records of their verification program, retain them for at
least two years, and make them available to FDA upon request.
A copy of one of the FDA's letters to a trade association
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