REGULATORY REPORT
By Kathy Gombas and Howard Seltzer
The Reportable Food Registry:
A Valuable New Tool
for Preventing
Foodborne Illness
When Congress created the Reportable Food Registry (RFR) in Section 1005 of the U.S. Food and Drug Administration
(FDA) Amendments Act of 2007, FDA
was given the opportunity to develop a
useful addition to its armamentarium of
tools and techniques to prevent foodborne illness. In the law, which
became Section 417 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act), Congress directed that FDA establish an electronic portal
to which industry must, and public health officials may, report when
there is a reasonable probability that an article of human food or animal food/feed (including pet food) will cause serious adverse health
food or feed through the supply chain,
or both. In all circumstances, the RFR
makes significant sectors of the food and
feed industries partners with FDA in
tracking down food and feed that has
the potential to cause serious illness.
The RFR obliges manufacturers, processors, packers, and holders of food or
feed to notify FDA via an electronic
portal whenever they determine that
they have a reportable food, that is, “an article of food for which there is a reasonable probability that the use of, or
exposure to, such article of food will
cause serious adverse health consequences or death to humans or animals.” In addition, government public
health officials may voluntarily use the
portal to report information that may
come to them about reportable foods.
Dietary supplements and infant formula are exempted from the RFR requirements because reporting of adverse
events associated with them are covered
under other sections of the FD&C Act.
Because submissions to the RFR include supply chain information, that is,
the immediate previous source(s) and/or
immediate subsequent recipient(s) of a
reportable food, they help FDA identify
both the site where the adulteration may
have occurred as well as the locations of
food products moving through commerce to the retail level. As a result, the
RFR has already achieved several notable successes in removing adulterated
foods from the supply chain before any
illness associated with them occurred, of
which more is described later in this
article.
consequences or death to humans or animals.
In its first year of operation, the RFR has had an impact on the prevention of
foodborne illness. As Michael R. Taylor, FDA’s Deputy Commissioner for Foods,
has pointed out:
“The RFR represents an important tool for targeting our inspection resources, bringing
high-risk commodities into focus, and driving positive change in industry practices—all of
which will better protect the public health.”
What Is It?
Depending on the circumstances of a particular case, the RFR can be an early
warning of an adulterated food or feed, a map of the progress of an adulterated
How Does the RFR Work?
Mandatory Reporters
The persons who register facilities
with FDA that manufacture, process,
pack, or hold food or feed for consumption in the U.S. are responsible parties in
the language of the RFR and for them,
the requirements of the RFR are mandatory. The most important requirement is
that within 24 hours of a responsible
party determining that a facility has an
instance of reportable food, they must
