HHS Prepares to Open FDA Offices in China, India, Europe, Latin America, Middle East

The HHS Secretary notes that HHS is making steady progress to better safeguard the U.S. supply of food and medicines, though much work remains, noting that in the past year, labs and equipment have been upgraded, additional staff has been hired, and implementation of product safety agreements with key trading partners, including China, has begun.

FDA's First Overseas Office Will be in China

HHS states that FDA's first overseas office will be in China. The U.S. government recently secured formal approval for the office from China.

FDA's first staff will be in place in Beijing in 2008, with additional staff to be posted in 2009. Staff is also scheduled to be posted in Shanghai and Guangzhou next year. HHS anticipates a total of eight FDA nationals in China.

In November 2008, HHS Secretary Leavitt is scheduled to meet with Chinese health officials to review mutual efforts to ensure the safety of food and medical products consumed by the two nations, particularly imported goods.

Second FDA Overseas Office Planned for India

HHS states that it plans on establishing its second FDA overseas office in India, with staff first posting to New Delhi in 2008 and at least one additional office to follow in 2009. Plans at present are for 10 U.S. nationals to be posted in India. The U.S. government is in the process of pursuing India's formal approval.

FDA Personnel Would Work with Local Authorities, Industries to Improve Safety

In both China and India, FDA personnel will work closely with local authorities as well as industries that ship food and medical products to the U.S. 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.

Additional FDA Offices in Europe, Latin America, and the Middle East

HHS will also be opening overseas FDA offices in Europe and Latin America before the end of 2008, with a fifth office in the Middle East to follow soon in early to mid-2009.

HHS Working on Product Safety MOUs with 9 Latin American Countries

HHS officials are also working to conclude Memoranda of Understanding with Belize, Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Nicaragua and Panama to work together on product safety. Their collaborations could include information-sharing on their respective regulatory systems and joint workshops and training on the safety of food and medical products. The parties will also make efforts to find opportunities for joint training for food-borne illnesses and the oversight of food traded internationally.

Coordination Etc. with Trading Partners Part of Import Safety Action Plan

HHS states that increased collaboration and coordination with trading partners and companies exporting goods to the U.S. is a central component of the Import Safety Action Plan proposed in November 2007 by an interagency working group. In addition to border checks, the Import Safety Action Plan calls for partnering with producers of goods overseas to build in quality every step of the way.

(See ITT's Online Archives or 11/08/07 and 11/09/07 news, 07110815 and 07110910, for BP's two-part summary of the Import Safety Action Plan.)

Some proposals in the Import Safety Action Plan require new authorities to be granted by Congress. The Administration has repeatedly urged congressional action on these, but to date no legislation has passed. Examples include the following:

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

HHS press release (dated 10/16/08) available at http://www.hhs.gov/news/press/2008pres/10/20081016a.html.