Will FDA Meet its July 4 FSMA Deadline? Don’t Hold Your Breath
Tags: auditors, ben england, deadlines, FDA, food safety modernization act, foods, FSMA, HARPC, IFT, implementation, Intentional Adulteration, program, risk based, sanitary, third party, timeline, transportation, Voluntary Qualified Importer, VQ?IP
It’s that time of year again… Time for another FSMA deadline! The pressure is on for the U.S. Food and Drug Administration to meet yet another critical date with multiple deadlines imposed by the Food Safety Modernization Act (FSMA). Every 6 months a deadline rolls around and every 6 months FDA has stumbled past it with varying degrees of success in delivering what Congress instructed. This July 4th is another such deadline with multiple important FSMA items due. Whereas it might be expected to stir up some panic at FDA (because the implementation date for major FSMA provisions is a mere 6 months), the politics are quite different this election year. We have been predicting FDA will propose no FSMA rules until after the election because to do so would require the Obama Administration to scale back the regulatory impact. If FDA waits until after the election, the Administration can be more rigorous with the regulations — whether President Obama wins or loses.
So will FDA turn in its homework on time? Don’t hold your breath. Here’s what’s due:
- In cooperation with IFT, a report on the traceability pilot project from earlier in the year.
- Hazard analysis regulations for food-related facilities under the Hazard Analysis and Risk-based Prevention Controls (HARPC) provision
- Establishment, with Customs, of the Voluntary Qualified Importer Program (VQIP) and issuance of a guidance document explaining how to participate (FDA should have done this years ago and did not need FSMA to initiate it. Doing this first would give FDA a tremendous amount of information about how the industry is already controlling risks related to imported food so it could develop its Foreign Supplier Verification Program with some light on the subject. But, as is often the case, FDA is still in the dark about the current compliance status of foreign firms and U.S. importers)
- Regulations proposing accreditation of third-party auditors
- Regulations proposing ways to protect against intentional adulteration of foods (Seriously Under-Reported-Issue Alert!!)
- Regulations proposing for the sanitary transportation of food
This list is made all the more ominous when you take into account how much was due at the last benchmark, which hasn’t been completed yet. In January of 2012 FDA had another laundry list of items FSMA required the agency to implement and America is still waiting for those. Can FDA pick up the slack and not only publish its January items but also its July 4th items? Not likely, says FDAImports.com Founder and CEO, Benjamin England. “It’s an election year in the middle of vacation season,” he stated. “I would be very surprised if FDA published anything at all, especially one of the more critical FSMA items. I’d expect to see something by the end of the year, maybe, but not until we’re all wearing scarves again.”
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