J.O. Alvarez, Inc. BLOG

In a Feb. 4 speech to the Center for Strategic and International
Studies, Food and Drug Administration Commissioner Margaret
Hamburg laid out the elements of the “new approach” the agency is
adopting to ensure the safety of imported food and drug products.
Hamburg said FDA is “moving from a system that places most of the
regulatory burden on the FDA’s modest inspection force, to one that
creates greater oversight at points further back along the production
chain.” The FDA needs to know “who is making our foods and drugs
[and] where they are located,” she said, “and we need to be sure
that these facilities are being inspected and are accountable for what
goes into their products as well as the products they produce.”
Hamburg asserted that “massive change is required for FDA to be
able to keep up with a globalized economy.” It is “simply not
possible to count on interdicting everything harmful at our borders,”
she said, noting that an estimated 20 million shipments of FDA regulated
imports will enter the U.S. in 2010 but that less than 1%
are likely to be examined by FDA inspectors. “Similarly,” she added,
“FDA cannot alone conduct a sufficient number of inspections at
foreign manufacturing facilities to help ensure product safety.”
As a result, Hamburg said, “FDA must adopt a new approach …. an
approach that takes into account the entire supply chain and its
complexity; and an approach that will address product safety by
preventing problems at every point along the global supply chain…
from the raw ingredients… through production… and distribution… all
the way to U.S. consumers.” To apply this “basic principle of
prevention to all imports,” FDA is taking the following steps.
Better Controls at Point of Production. Hamburg said FDA is
moving into a phase where it works with regulators, manufacturers
and suppliers wherever they are. There are now permanent FDA
offices in China, India, Costa Rica, Mexico, Chile and, soon, Jordan
that are aiding aid FDA efforts to help these countries and others to
establish the regulatory powers necessary to support safe products
for their own domestic use and a strong, reliable export market. FDA
also now has more than 30 agreements with foreign counterparts to
share inspection reports and other non-public information that can
help the agency make better decisions about the safety of foreign
products.
Holding Importers Responsible for Supply Chains. “In this day
and age,” Hamburg said, “companies must be able to effectively
demonstrate that safety, quality and compliance with international
and U.S. standards are built into every component of every product
and every step of the production process.” Best practices already in
use by some companies “need to become standard practice
throughout industry,” she said, and FDA plans to work with industry
to set standards for technologies and other approaches that can help
them strengthen the safety of their supply chains.
PREDICT System. Stating that FDA has a responsibility to deploy
its resources as strategically as possible, Hamburg formally
announced the Predictive Risk-Based Evaluation for Dynamic Import
Compliance Targeting (PREDICT) system. This new Web-based risk
assessment tool will replace the admissibility screening function of
the legacy OASIS system, assist entry reviewers in targeting higher risk
shipments for examination and expedite the clearance of lower risk
cargo (provided that accurate and complete data are provided
by importers and entry filers). PREDICT was piloted in Los Angeles
and is currently being brought online in New York, and Hamburg
expressed hope that it will be up and running around the U.S. by the
end of the spring.
According to Hamburg, PREDICT uses a variety of assessments to
rank import shipments according to risk. “It considers everything
from whether a product is intrinsically risky–raw seafood falls into
this category– to information we’ve acquired from previous
examinations of shippers or producers,” she said. “We can even add
information on things like floods, hot weather or market conditions
that suggest whether a particular shipment is at risk of being spoiled
or shoddy. These and other factors are added up to give a risk score
—and the riskiest items are the ones that our investigators will check
first.” Hamburg said PREDICT will automatically flag potentially risky
shipments but will also give lower risk scores to more innocuous
materials, which can then be cleared rapidly through FDA inspection.