By Ricardo Carvajal -
The question (in the title of this post) occurred to us in preparing for FDLI Food Week 2015, taking place as this is written. When FDA issued its Pathway to Global Product Safety and Quality in 2011, the agency set forth this ambitious objective: “Over the next decade, FDA will transform itself from a domestic agency operating in a globalized world to a truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders.” As we noted in a prior posting, a fundamental obstacle to this objective could well be a lack of additional funding, without which FDA contends that it “will be unable to... adequately assure the safety of imported food by building and implementing the import safety system mandated by FSMA.”
Funding limitations aside, there are challenges inherent in the rapid expansion of FDA’s footprint in the past four years to encompass constituencies over which the agency historically has exercised more limited oversight. As noted by FDA, “[f]or the first time, importers will have explicit responsibility to verify that their foreign supplies have adequate preventive controls in place and that the food they ship to the U.S. is otherwise safe.” Also for the first time, the agency will actively regulate farms (through the produce safety rule) and restaurants (through the menu labeling rule). Fully implementing each of these initiatives will require the agency to devise appropriate enforcement strategies. That is a critical piece of the puzzle without which the regulated industries will have difficulty assessing how best to target their compliance efforts – but one that might not be in place for some time to come.