FDA Doesn't Plan on More Foreign Offices Despite Imported Food Outbreaks
In February 2012, the Food and Drug Administration submitted its annual report to Congress on the agency's foreign offices, pursuant to the Food Safety Modernization Act (FSMA). According to FDA's report, while strengthening the "product safety net" around the world is a core part of FDA's operating model and recent reports have found an increase in food borne illness caused by imported food, the agency currently doesn't have plans to open additional foreign offices.
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(FDA foreign posts carry out a range of activities, including (i) enhancing relationships with foreign government counterparts and working with them more closely on in-country efforts to help ensure product quality and safety; (ii) obtaining information about products destined for the U.S.; (iii) informing foreign governments and industry of FDA standards, guidance, and requirements; (iv) conducting foreign inspections; (v) scanning the local environment for incidents and activities that might have an effect on the availability and/or safety of products destined for the U.S.; etc.)
FDA Report Finds 15% of U.S. Food Supply Is Imported, 75% for Seafood
The FDA's report outlines some of the current challenges the agency faces because of the globalization of the products for which it is responsible domestically. These challenges are highlighted by the significant increase in the volume of FDA-regulated products imported from around the globe; over 300,000 facilities in 150 different countries produce products that enter the U.S. through over 300 ports of entry. Approximately 15 percent of the U.S. food supply is imported, and this percentage increases to about 75 percent for seafood and 50 percent for fruit.
CDC Report Finds Increase in Food borne Disease Caused by Imported Food
A recent Centers for Disease Control and Prevention (CDC) report has found that food borne disease outbreaks caused by imported food appeared to rise in 2009 and 2010, and nearly half of the outbreaks implicated foods imported from areas which previously had not been associated with outbreaks.
From 2005 to 2010, 39 outbreaks and 2,348 illnesses were linked to imported food from 15 countries. Of those outbreaks, nearly half occurred in 2009 and 2010. Overall, fish were the most common source of implicated imported food borne disease outbreaks, followed by spices. Nearly 45 percent of the imported foods causing outbreaks came from Asia.
FDA Operating Model Includes Assembling Global Coalitions of Regulators
In response to the changing global environment, in July 2011, FDA issued a report entitled, "Pathway to Global Product Safety and Quality." One of the core building blocks of FDA's new international operating model is to assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world. FDA's establishment of foreign posts in strategic locations around the world and deployment of staff to various postings enables FDA to work more closely with foreign government counterparts and others within the "in-country" community on product quality and safety.
FDA Has Established 13 Foreign Posts, but Has No Plans to Open More
In its report, FDA states that it has no plans to open additional foreign posts at this time. As of June 30, 2011, agency has established 13 foreign posts in the following areas:
- China -- Posts in Beijing, Shanghai, and Guangzhou;
- India -- Posts in New Delhi and Mumbai;
- Latin America -- Posts in San Jose, Costa Rica; Santiago, Chile; and Mexico City, Mexico;
- Europe -- Posts in Brussels, Belgium; London, UK; and Parma, Italy;
- Sub-Saharan Africa -- Post in Pretoria, South Africa; and
- Middle East and North Africa -- Post in Amman, Jordan.
Most Recently Requested to Open Post in Brazil in Early 2011
However, in early 2011, FDA requested permission to establish a post in Brazil, recognizing the increasing number of exports from Brazil to the U.S. FDA states opening a post in Brazil would enable the agency to better leverage resources with Brazil and the region by building on previous technical collaborations and Brazil's leadership in the region. Areas of interest in Brazil and the region include medical devices, tobacco products, and counterfeit medicines.
(See ITT's Online Archives 11062027 for summary of the FDA's July 2011 report, which stated that FDA's global supply chain strategy includes addressing trends of increasing imports and growing demand.
See ITT's Online Archives 12022414 for summary of FDA's plans to issue proposed rules to implement parts of the FSMA, including third-party certification, foreign supplier verification, etc.)