submit a report to FDA through the Department of Health and Human Services’ Safety Reporting Portal (SRP) at
www.safetyreporting.hhs.gov.
As used in relation to the RFR, the
term “responsible party” does not refer
to the responsibility for a food being
adulterated, but to the responsibility to
report if a facility determines or is notified that it has or has had a reportable
food in its possession. There should be
no confusion about responsible parties—
if you are registered under Section 415
of the FD&C Act and you determine
that you have or have had an article of
food that meets the definition of a reportable food, you must report it to the
portal. There is one scenario, however,
when a responsible party does not have
to report. This is true only when all three
of the following criteria are met:
1. The adulteration originated with the
responsible party AND
2. The responsible party detected the
adulteration prior to any transfer to another person of such article of food
AND
3. The responsible party
a. corrected such adulteration or
b. destroyed or caused the destruc-
tion of such article of food
A transfer to another person occurs
when the responsible party releases the
food to another person. “Person” is de-
fined in Section 201(e) of the FD&C Act
as including individuals, partnerships,
corporations, and associations. FDA
does not consider an intra-company
transfer in a vertically integrated com-
pany to be a “transfer to another per-
son,” where the company maintains
continuous possession and control of
the article of food. For example, if Com-
pany A owns a processing plant, ware-
house facility, and distribution facility,
the intra-company transfer from the pro-
cessing plant to the warehouse facility
and/or the warehouse facility to the dis-
tribution facility would not be consid-
ered a transfer to another person.
“The RFR represents an important tool for
targeting our inspection resources, bringing
high-risk commodities into focus, and driving
positive change in industry practices...”
may not file a report on any firm’s behalf. However, if officials identify a reportable food as part of their inspection
or regulatory activities, they can inform
the firm that submission of a reportable
food report may be required.
Voluntary Reporters
The law that created the RFR gives
government public health officials the
option of providing voluntary submissions to the portal if they have information about reportable foods, but they
Submitting a Report
Mandatory or voluntary reporters
can go directly to the SRP home page
at www.safetyreporting.hhs.gov, or
they can go to www.fda.gov/
ReportableFoodRegistry (Figure 1) where
they will find a wealth of RFR informa-
tion and guidance, as well as a button
that will also take them to the home
page of the SRP. There they will have
the option of creating an account or
submitting a report as a guest. Creating
an account provides submitters with
many advantages. It allows reporters to
save both partial and completed reports;
any time they return to the portal, their
new or amended reports will be pre-pop-
ulated with their contact information;
and they can view any previous submis-
sions they have made via the SRP. Per-
sons reporting as guests receive none of
these benefits.
After the whether-to-create-an-ac-count-or-not decision has been made,
the portal will lead submitters through a
series of screens that captures the information that FDA needs to get reportable
foods out of the food supply as quickly
and efficiently as possible.
The information required in submit-
ting a report by a responsible party is
what FDA needs to know in order to
investigate:
• FDA registration number of the re-
sponsible party in the case of a
mandatory report
• Date on which the article of food was
determined to be a reportable food
• A description of the article of food,
including the quantity or amount
• Extent and nature of the adulteration
• Results of any investigation of the
cause of the adulteration, if it may
have originated with the responsible
party, when known
• Disposition of the ar-
ticle of food, when known
• Product information
typically found on packag-
ing, including product
codes, use-by dates, and the
names of manufacturers,
packers, or distributors suf-
ficient to identify the article
of food
When the report is sub-
mitted, the system issues an
Individual Case Safety Re-
port (ICSR) number, an
identifier unique to each
report.
If some of the required
information is not available
within the 24-hour reporting window, the RFR allows amended reports to be
Figure 1: FDA’s Reportable Food Registry home page:
www.fda.gov/ReportableFoodRegistry
