In August, during the 100th anniversary meeting of the
American Feed Control Officials
(AAFCO), held in Washington, DC, USA, a topic of imminent
importance to the petfood industry came up for discussion:
implementation of the
US Food and Drug
(FDA) Reportable Food Registry.
The formation of a means for food and feed companies to
report incidents of adulteration in a timely manner is a
mandate of the FDA Amendments Act (FDAAA) of 2007. This
provision was put in place in response to the perceived delays
in reporting incidents of contamination, which may have
exacerbated their adverse impacts on human and animal
Perhaps the most notable event that prompted this new law
was the contamination of petfoods with melamine and related
compounds earlier in 2007. The mandatory reporting system is
intended to help FDA quickly track patterns of adulteration and
support efforts to target the agency's limited inspection
resources more effectively.
Required to report
The Reportable Food Registry requires the responsible party
to report as soon as practical (but no later than 24 hours) any
discovery where there is reasonable probability that the use
of, or exposure to, a food or feed will cause serious adverse
health consequences or death to humans or animals. The
responsible party is the person who submits the facility
registration under the Bioterrorism Act of 2002. These reports
must be submitted through FDA's electronic portal, due to be
as of September 8. Failure to comply with this reporting
requirement will be a felony.
While the portal for submitting reports is not available for
viewing at the time of this writing, an FDA official at the
AAFCO meeting described the submission process as "easier than
doing your income tax."
Instructions will be available on the Web page.
A report must include:
Responsible parties must also report the results of any
investigation into the cause of the adulteration and the
disposition of the adulterated item. This latter information
may be unknown or incomplete at the time of the first
submission but, when completed, must be included in an amended
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.
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 party should err on the safe side and report the
incident. FDA would then determine if the food was a reportable
Obviously, a reportable food indicating further action-for
example, a recall-will be public knowledge at some point. What
is still unclear from 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
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.
Public meetings invited comments and provided updates
Committees discussed key proposals such as a possible shift in the oversight of animal feeds
The mid-year meeting addressed several regulatory matters affecting petfoods
It gives more direct control to CVM in establishing and maintaining ingredient definitions
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