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FDA Outreach in Latin America, Part II

As part of our ongoing expert Q&A series: An in-depth look at how the FDA’s headquarters in Latin America works to promote safer food

With over 220,000 foreign food facilities from over 150 countries registered to import food into the United States, the U.S. Food and Drug Administration (FDA) has a lot to keep track of.

Food Safety News recently had a chance to chat with Dr. Paul Seligman, regional director of Latin American programs for the U.S. Food and Drug Administration (FDA), about how the agency is working to improve food safety in the region.

Dr. Seligman, based at FDA’s Latin American regional headquarters at the U.S. Embassy in San Jose, Costa Rica, has a broad jurisdiction–all of Latin America and the Caribbean–and only 16 staff, based in various regional offices and at FDA headquarters in Maryland.

See PART I of our discussion with Dr. Seligman, on the FDA’s operations in Latin America, here.


Q: What are the biggest challenges facing FDA in Latin America?

A: I think for us our biggest challenge is extraordinary diversity. We’ve got huge countries like Brazil and Mexico, and then we’ve got teeny little island countries in the Caribbean. We’ve got countries that have fairly mature and sophisticated regulatory infrastructures and strong university systems, and others that are less sophisticated or less organized. I think the biggest challenge is just the vastness of the part of the world that we have to cover. 

Other challenges, as in any other new organization and any new group is that a lot of groups that have been working in the region for many, many years ahead of us, that includes U.S. governmental organizations like the U.S. Department of Agriculture and their foreign Ag service, as well as the Department of Commerce, and USAID, as well as other international organizations: the Pan American Health Organization, the International Institute for Cooperation on agriculture.  That happens coincidentally to be located in San Jose, Costa Rica.  There are just so many organizations and groups with a lot of experience, a lot of resources, a lot of knowledge. I think on of our biggest challenges will to be to find the best way and the appropriate way to work with and interface with and interact with these very experienced, very capable organizations. 

Q: How will the FDA food safety reform bills moving through Congress impact your operations on the ground? 

A: I don’t know yet, because I don’t know what those bills will look like, but I can tell you for sure that once they are passed, they will no doubt impact us all. 

It’s not just Latin America, but any manufacturer and company throughout the world that seeks to import to the United States is always attentive in looking carefully to new guidances and regulations and laws and statutes.  I’m sure that when those bills are finalized, I have no doubt that it will impact us. We have already received many, many requests for training and for education, and I’m sure that will be one of the first series of requests that we will receive when legislation passes–if it’s passed–will be for us to explain what’s going on, interpret it, and explain what FDA’s approach is, and policies will be to implement any new legislation.
Q: How does the office ensure recalled US products are removed from shelves in Costa Rica, or is this primarily a responsibility of the local Ministry of Health?

A: We have a very active recall process within the FDA.  We send out electronically, as I suspect you are aware, on a daily basis, a number of recalled products both nationally and internationally. 

When we see a Class I recall, which has the potential to seriously harm health, one of the first questions we ask of the manufacturers is where is the product being shipped, and who are your foreign customers, and as soon as we get that information, we contact directly the regulatory authorities within those countries and inform them of the recall and all the information related to that recall. 

We just had a recent example of a medical device actually where we informed the Costa Rican government of that.  And you’re absolutely right, it is their responsibility once we’ve made that information available to communicate with their health care providers, pharmacies, grocery stores, whatever the nature of the recall is, to ensure that the people are informed and the product is removed from the shelf.  And very often, the manufacturers will leave that recall notice and provide instructions on which lot numbers, which product numbers need to be removed or taken off the shelf, and then how to dispose of those recalled products.

See Food Safety News tomorrow for Part III of our discussion with Dr. Seligman.

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