The U.S. Food and Drug
wants to know the life
story of the imported
produce in your salad
before it arrives on U.S.
shores, let alone your dinner table.
Where was the lettuce grown? What
processing and packing plants did it go
through before arriving in the United
States? And who is transporting it?
FDA is finding the answers through
a global extranet that is used for
registration and prior shipment notice
of all food importsÂa requirement
signed into law as part of the Public
Health Security and Bioterrorism
Preparedness and Response Act of 2002.
The system, which rolled out in
October 2003, keeps track of nearly
200,000 food facilities, about half of
which are foreign. An estimated 200,000
have yet to register.
"It provides safety to the American
public," says James Rinaldi, chief
information officer at the FDA in
Rockville, Md. "It is used to make sure
we're as secure across our borders as we
can be when it comes to food in the
FDA is responsible for all domestic
and imported food except for meat,
poultry and egg products that are
under the exclusive jurisdiction of
the Agriculture Department. The FDA
regulates about 80 percent of the nation's
The Bioterrorism Act requires FDA to
"give high priority to making necessary
improvements to the information
management systems of the Food and
Drug Administration that contain
information related to foods imported or
offered for import into the United States
for purposes of improving the ability of
the Secretary to allocate resources, detect
the intentional adulteration of food, and
facilitate the importation of food that is
in compliance with this act."
Racing the Clock
FDA's extranet runs on an Oracle
database platform with Unix servers, and
is built as a Java-based application. A
high-speed network keeps information
The $16.5 million project faced
daunting challenges for the 480-person
FDA IT staff and contractors. With less
than 10 months to build the system from
scratch, the team had to move quicklyÂ
but with future uses in mind.
"We designed [the registration side of
the project] initially to be used for any
registration we might need in the future,"
such as drug import registration, Rinaldi
says. "We started with food because it
was the highest priority."
The extranet application also crosses
several FDA groups. These include the
agency's Center for Food Safety and
Applied Nutrition; the Office of
Regulatory Affairs and that office's
inspectors across the country who
inspect imported food shipments; the
Centers for Devices and Radiological
Health; and the Office of the FDA
The task was complicated by evolving
regulations that kept changing the
"They were developing the regulations
at the same time that we were developing
the system," says Ray Russo, director of
FDA's Office of Business Enterprise
Solutions and one of the project leaders.
Final requirements for the system were
passed on Oct. 10, 2003, just days before
the extranet system was rolled out.
"We were getting changes not only up
to the time we implemented, but some
[changes] a little after we implemented,"
The extranet was up and running on
Oct. 16, 2003. At its peak, it registered
more than 12,000 facilities a day that
were bringing food in from China, Italy
and the Caribbean. Today, FDA receives
registrations from about 200 facilities
The agency conducted an extensive
education program for food importers
worldwide through a series of broadcast
and Web-based events that involved the
IT staff, according to Rinaldi. FDA
informed companies about the processes
and procedures now required to do
business with the United States.
Three large public meetings were held
via satellite downlinks in three languages.
Other public meetings were held at sites
coast to coast, and FDA officials gave
numerous presentations to trade groups
and industry associations.
Today, food manufacturers/processors,
packers and storage operations can
register their facilities at the www.fda.gov
Web site and by clicking on the
registration application. Registrants must
provide information on each facility
where they do business, all trade names
they use and information about certain
categories of food each facility handles.
Foreign registrants also must include
the name of the facility's U.S. agent. The
registration form is fairly simple to fill
out, although the prior notice form is a
bit more complex, Rinaldi says. However,
online help is provided.
Old System, New Purpose
More familiar to importers and food
brokers is the prior-notice system.
FDA collaborated with the Bureau of
Customs and Border Protection to
modify CBP's Automated Commercial
System (ACS), already used by importers
to supply import information required by
Customs. Prior-notice requirements were
added to the Customs system and linked
to FDA's internal import system.
"We had most of the information there
to begin with; we just needed to add a few
extra data elements Â and make sure it
conformed to the Bioterrorism [Act]
requirements," says Michael Toms, ACS
specialist at Customs.
After importers give notice of
incoming food shipments, Customs
officials give FDA the information it
needs, according to Russo. "The only
information that has to come in through
the prior-notice Web interface directly is
from those importers who are very small
or not brokers, and that's only about 10
percent of the prior notices coming in,"
The familiarity most importers have
with ACS and its ability to supply all
necessary information at one location
simplifies compliance with the new law.
FDA receives about 25,000 notifications
about incoming shipments each day.
With the Customs system, FDA has
been able to keep the time needed for
prior notice at levels lower than expected:
from an estimated 12 hours to two hours
before arrival by land via road, four hours
before arrival by air or by land via rail or
eight hours before arrival by water.
FDA officials say the project points
to a wave of government agencies'
collaborative IT efforts spurred by
September 11. "People in the government,
especially in Health and Human Services,
Customs and the other agencies, now
talk together with one voice," says Cam
Boyce, an FDA spokesman. "Since 9/11,
we've made many improvements. We
now know exactly who to contact at our
sister agencies, and our contact lists are
constantly being updated."
WHAT'S COOKING NEXT AT FDA
With its $185 million IT budget for 2004Âa
reduction from prior yearsÂthe Food and
Drug Administration is finding ways to do
more with less, while improving IT services.
Last October, the agency established
shared IT services to pull together all
infrastructure components across the
agency, including computers and networks.
On March 30, all IT components across
the FDA began reporting directly to CIO
"It will save taxpayers money because
we'll develop systems using more advanced
and common technology," Rinaldi explains.
"We'll re-use, and we'll have a preference
to buy versus build. It will allow us to utilize
more folks across our IT community to be
involved in our high-priority projects."
One of those projects is electronic
labeling of drug prescriptionsÂa huge
safety concern at the FDA. Rinaldi's team is
in the planning stages for an infrastructure
that would support labeling. "When a
pharmaceutical company sends us labeling
information, our reviewers can edit it
immediately and put it in a location where
pharmacies can pull up the approved label
at any time," Rinaldi says. "That reduces the
risk of outdated labeling." The project will
need supporting legislation before FDA can
put it into use.
Rinaldi is also evaluating ways to speed
the reporting of "adverse events" of medical
products to FDA. Electronic submissions, as
opposed to paper, speed the notification
process of drug and device problems so
that resolutions can be achieved faster.
FDA now accepts online voluntary adverse
event reports for medical products through
MedWatch, which lets FDA quickly receive
and electronically send approved safety
information for safer use of medical
products in clinical environments.
For Rinaldi, his team's mission is clear:
"Our role in IT is to make sure that the
experts we have in the FDA have access to
the information they need to do their jobs."
Peak number of registrations
in one day:
Facilities registered to date:
Facilities still to register:
Number of shipment
Nation's food supply under
Source: Food and Drug Administration