FDA may impose other requirements after evaluating the report.
This could include additional information as needed for FDA to conduct
its investigation and notify the immediate previous source and/or immediate subsequent recipient(s) of the
adulterated item, who in turn may
also have to file reports. Finally, there
are requirements to keep records on
all reports for two years.
Failure to
comply
with this
reporting
FDA at this juncture is whether a
report that is later determined by the
agency not to be a reportable food will
still be made available to the public. If
it is, this could have a negative impact
on the inclination for responsible
parties to file reports when the probability of harm is borderline.
Exemptions apply
requirement
will be a
felony.
The responsible party will not be
required to submit a report if:
It is assumed that the severity of
the potential penalties for noncompliance will dissuade this from
happening. Some have also expressed
concern that this reporting requirement may actually discourage routine
safety testing. ●
➤ The adulteration originated with
the responsible party; AND
➤ The food was in full control of the
responsible party at time of detection of the adulteration; AND
party should err on the safe side and
report the incident. FDA would then
determine if the food was a reportable food.
➤ The cause of adulteration was
determined and corrected, or the
food was destroyed.
Assumedly, a report also would
not be required if the adulteration did
not result in a reasonable probability
of serious harm. At this time, though,
guidance on how this determination
is to be made by the responsible party
is lacking. The impression given by
FDA is, if in doubt, the responsible
Publicly available
Obviously, a reportable food indi-
cating further action—for example, a
recall—will be public knowledge at
some point. What is still unclear from
Dr. Dzanis is a writer and
consultant on nutrition, labeling
and regulation. Contact him at
Tel: +1.661.251.3543; E-mail:
dzanis@aol.com.
U.S. farmer owned, the Western
Sugar Cooperative has proudly been
in business for over 100 years. From
our locations in Billings, MT and Lovell,
WY our beet pulp pellets provide a
highly digestible source of fiber
and protein. We have the highest
quality standards and provide a very
reliable and safe product.
