RM Global Health

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.

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.

Reviewed by Ramaz Mitaishvili, MD