Date: July 9, 2008
For Release: Immediately
Contact: HHS Press Office
(202) 690-6343

Headline: HHS Announces New International Programs to Enhance Drug and
Food Safety Joint Inspections with European Union and Australian
Regulators; Third-Party Certification Program Are Latest Steps toward
Implementing New Import Strategy

U.S. Health and Human Services (HHS) Secretary Mike Leavitt today
announced two groundbreaking programs designed to enhance the safety of
food and medical products exported to the United States.

“These programs will significantly increase our collaboration with
international and private sector partners to enhance the safety of
imported food and medical products,” Secretary Leavitt said. “Working
together, we intend to offer expedited access to those products shown to
meet our standards and to focus more of our resources on those products
that present higher risks.”

Secretary Leavitt made the announcement in a speech to hundreds of
industry leaders at an Import Safety Summit in Washington. He described
the twin initiatives as the latest steps in a fundamental,
government-wide shift to implement the Interagency Import Safety Action
Plan finalized in November 2007. Historically, U.S. authorities have
primarily relied on intervening at the border to intercept unsafe goods.
The new strategy calls for actively working with trading partners to
help ensure they build quality into every step of a product’’s life
cycle, targeting critical points where risk is greatest, and focusing
attention and resources on these areas.

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The first initiative is a pilot project the HHS Food and Drug
Administration (FDA) is undertaking with its counterparts in the
European Union and Australia to jointly plan, allocate for and conduct
inspections of drug-manufacturing facilities. The project will
initially focus on makers of active pharmaceutical ingredients. If
successful, this program could expand to include other types of
manufacturing facilities. The novel collaboration will allow HHS/FDA to
more fully take advantage of information gathered by trusted inspection
and regulatory systems in other countries.

The second initiative is a third-party certification pilot program
involving aquacultured (farm-raised) shrimp. HHS/FDA is seeking the
participation of certification bodies that currently certify foreign
processors of aquacultured shrimp for compliance with the FDA’’s seafood
regulations. The project is designed to help HHS/FDA learn how to
evaluate third-party certification programs and implement them in the
field — a key part of leveraging the additional resources of the
private sector and other regulators.

Additional information about import safety initiatives is available at
www.importsafety.gov.

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Note: All HHS press releases, fact sheets and other press materials are
available at http://www.hhs.gov/news.