The Food Safety Modernization Act (FSMA) enacted January 4, 2011 set forth a variety of benchmark reporting requirements for FDA, one of which is a summary of the FDA’s foreign offices and their progress and direction for the future. The FDA has recently submitted this report and it gives us a glimpse into the international intentions of FDA. Being in the FDA Import Regulatory Consultant business, we think that’s kind of useful. FDA’s report discusses the agency’s vision for its field offices, a distinction between “posts” and “offices,” the tasks and activities of foreign posts, the past progress and future strategies related to foreign posts.
REPORT SUMMARY
The core focus of foreign FDA offices is on U.S. health priorities and FDA mission.
There are 13 FDA foreign posts as of June 30, 2011. Being fearful of the number 13 generally, FDA will open only one more foreign post in Brazil, bringing the number to 14. FDA’s current posts are located in:
China (Beijing, Shanghai, and Guangzhou)
India (New Delhi and Mumbai)
South and Central Americas (San Jose, Costa Rica; Santiago, Chile; Mexico City, Mexico)
Europe (Brussels, Belgium; London, UK; and Parma, Italy)
Sub-Saharan Africa (Pretoria, South Africa)
Middle East and North Africa (Amman, Jordan)
Foreign Post Activities Include:
Enhancing relationships with foreign government officials and working with them to help ensure product quality and safety
Obtaining information about products destined for the United States (I wonder what the foreign governments think of this)
Informing foreign governments/industries of FDA standards, guidance, and requirements
Assisting foreign governments in strengthening their own regulatory capacities
Scanning the local environment for issues that might have an effect on food availability and safety
Conducting foreign inspections (finally we get to it…)
Food Import Statistics
There are over 300,000 food facilities located in 150 different countries
Products that enter the United States can enter through over 300 ports of entry
Approximately 15 percent of the U.S. food supply is imported
75 percent of seafood and 50 percent of fruit is imported
Observations
There are 8 full time FDA staff for all of China and 2 locally engaged staff. That’s 10 people assigned to a country of 1.3 billion people and a whole lot of food growing, harvesting, manufacturing, warehousing, and supply chain activity. Putting this into perspective, 10 people in China is the same as FDA assigning about 3 people to oversee the entire USA food manufacturing and distribution business. If this foreign office idea is such a good one, and if the goal of FSMA is to solve the food safety problems at the point of origin, not at the border, one has to wonder why FDA is not assigning more resources to its China offices.
FDA lists “conducting inspections” last in its “foreign posts activities” list. Although this is not overtly a list of priority activities, it bears repeating that conducting inspections is last on the list because most of FDA’s foreign inspections are conducted by stateside personnel that spend resources taking trips to the foreign location specifically for that inspection (and bill the company for it if it happens to be a “re-inspection”).
This report proves that the impact of FDA’s foreign posts on manufacturers and importers, whether beneficial or detrimental, is barely a blip on the radar screen. The role of foreign posts isn’t changing although it is yet to be seen how FDA’s risk-based thinking will trickle down to foreign office policy and behavior.
Conclusion: For now, FDA’s foreign office experiment will be expensive, but it will not produce dramatic changes in supply chain evaluation or facility inspections for foreign companies and importers.
Read the full report here
