Pandora’s (IT) Box at FDA

Mar 29, 2012 | Law & Regulatory

FDA Database

Technology is central to the success (or even existence) of FDA’s food tracking and tracing pilot currently underway as part of FSMA’s new authority grant to the Agency.  If you have not read our first blog about the pilot conducted by FDA and IFT please read that here now.  What the statute accurately communicates but vastly underestimates is the difficulty and scale of the role of technology in the successful development of the program.   Sec. 204 2(B) of FSMA states that FDA should, “develop and demonstrate appropriate technologies, including technologies existing on the date of enactment of this Act, that enhance the tracking and tracing of food.”  Don’t miss what’s hidden between the lines here.  FDA is supposed to a) assess all the technologies and software currently used to track high-risk foods and then b) show how current or emerging technologies can all work together to plug into a yet-to-be-created food safety track and trace and reporting system that FDA will use to communicate outbreak information to the public and media.

It’s no secret that government agencies often use database systems that don’t speak the same language at all.  Even more frustrating to lawmakers is that most Federal agencies use different IT systems within their own agencies that don’t even play nicely together.  Information stove-piping or “siloing” is such a longstanding tradition in the U.S. government that it will be a challenge, to say the least, for FDA to take all the various data types in the private sector, make them talk to each other and then plug them into the FDA’s overall system.

The implications for current manufacturers and importers of high-risk foods are yet to be seen but there are a few takeaways from what FDA is saying:

  1. If you are a domestic or international manufacturer of high-risk foods you should already be thinking about track and trace systems.
  2. Begin to explore software systems that will open up the door for cross-platform IT reporting if you don’t have them already.
  3. Have an emergency plan in place for a foodborne outbreak that is turn-key (and technological) in nature and can be easily communicated and launched.

For more on FSMA please visit our website home base

Sources

http://fdatransparencyblog.fda.gov/2012/03/15/rapid-tracing-of-food-products-prevents-illness

http://www.fda.gov/Food/FoodSafety/FSMA/ucm270851.htm

http://www.fda.gov/Food/FoodSafety/FSMA/ucm247548.htm#SEC204

Subscribe To Our Blog!

Get up-to-date industry and regulatory news from the experts delivered straight to your inbox.

Thanks! You have been successfully subscribed.