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Nicolette Dalpino

FDA Compliance

Improving Import Safety

Published: Wednesday, November 19, 2008 - 10:12

(HHS: Washington) -- Last year, the United States imported more than $2 trillion worth of products, from roughly 825,000 importers, through more than 300 ports of entry. All projections indicate that this volume will continue to rise sharply over the coming years as the scale and complexity of international trade multiplies. As a key part of the Import Safety Action Plan to enhance product safety, the U.S. Department of Health and Human Services (HHS) will send the first U.S. Food and Drug Administration (FDA) staff to China, India, Europe, and Latin America before the end of 2008.

“We’re making steady progress to better safeguard our supply of food and medicines, although much work remains,” says Mike Leavitt, secretary of HHS. “In the past year, we’ve upgraded labs and equipment, hired additional staff, and begun implementing product safety agreements with key trading partners.”

Increased collaboration and coordination with trading partners and companies exporting goods to the United States is a central component of the Import Safety Action Plan, proposed in November 2007 by an interagency working group led by Secretary Leavitt. Previously, federal officials relied extensively on inspections at the border to ferret out unsafe goods, an approach that has not kept up with the exponential growth in global commerce. In addition to border checks, the plan called for partnering with producers of goods overseas to build in quality every step of the way.

Some proposals in the action plan require new authorities to be granted by Congress. Examples include the following:

  1. Authorizing the department to accredit highly qualified third parties to evaluate compliance with HHS/FDA requirements
  2. Authorizing HHS/FDA to require certification of designated high-risk products as an additional condition of importation
  3. Authority to refuse admission of imports from a firm that delays, limits, or denies HHS/FDA access to its facilities
  4. Empowering HHS/FDA to issue a mandatory recall of food products when voluntary recalls are not effective

The United States FDA recently opened it's first office in Beijing, with two more to follow in Shanghai and Guangzhou. HHS/FDA plans on establishing its second overseas office in the Republic of India. The U.S. government is in the process of pursuing India’s formal approval.

“The globalization of the food supply and medical product manufacturing has demanded that we do things differently,” says FDA commissioner Andrew C. von Eschenbach. “Through our Beyond our Borders initiative, we won’t have to send our experts to another country to work with foreign governments and regulated industry to improve our oversight, we’ll have staff living there and working on the ground 365 days a year.”

In both nations, personnel will work closely with local authorities as well as industries that ship food and medical products to the United States to improve safety efforts. Their activities will include providing technical advice, conducting additional inspections, and working with government agencies and private sector entities interested in developing certification programs.

HHS/FDA will also be opening overseas offices in Europe and Latin America, with a fifth office in the Middle East.

For further information, visit www.hhs.gov/news. For more information on the Import Safety Action Plan, visit www.importsafety.gov.

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Nicolette Dalpino

Nicolette Dalpino is a news editor for Quality Digest.