The 2012 elections are over! Celebrate or mourn. But either way, it’s now time to expect some stability and action as the sideshow comes to an end. As we predicted over the summer FDA did not release any of its new FSMA regulations before the election. In fact, the regulations are still jammed up at the Office of Budget and Management (OMB). Here are some predictions now that we know where we’re headed under the Obama administration.
FSMA
Expect the current regulations to be released from OMB in coming weeks. In fact, we have been predicting FDA will issue the FSMA proposed regs very near to the Thanksgiving holiday, probably the Friday immediately after Thanksgiving (that holiday having food as one of its major centerpieces and FDA’s favorite food holiday, July 4, being just too far away). We anticipate that the regulations for HARPC, Standards for Produce Safety and the Foreign Supplier Verification Program will come out as well as the Designation of High Risk Foods requirement. It’s possible we may also see the guidance for the Intentional Adulteration of Foods provision as well. January 2013 is another critical deadline for FSMA with such important provisions due as the recordkeeping requirements for High-Risk Foods, a report on Mandatory Recall Authority and a third-party auditor system. Expect some of these of these items to be released on time but none of the ones that were dependent upon prior missed deadlines (such as VQIP). Whenever the regulations do come out however, you can fully expect them to be rigorous. Companies need to prepare for this and make sure they submit comments during the prescribed time periods. We help companies submit comment to FDA and have seen substantial results in the past from our efforts so please make sure your voice is heard.
FDA
Big changes coming at FDA? Not likely. Expect continued pressure from industry and consumer advocacy groups for FDA to issue FSMA regs and guidance but also for FDA to add to its delay. For one reason, the FSMA expects FDA to solve problems and know information that FDA simply lacks the experience in handling. FDA will clamor for more money and will continue to reach for more regulatory power – more than granted to it under FSMA.
Imports
As was so evident from the debates, the U.S. economy is on everyone’s mind across the board. With another 4 years under the Obama administration expect the topic of global trade (especially for FDA-regulated commodities) to continue to be a hot topic for lawmakers and the private sector. When the Foreign Supplier Verification Program, HARPC regulations and Standards for Produce Safety all hit expect significant confusion as foreign manufacturers and food importers try to interpret them. FDAImports.com and ExportToUSA.com.cn will be developing training tools and resources for all of the crucial new FSMA provisions affecting imports. Subscribe to our blog so you know exactly what happens and how you should prepare.
Prop 37
Perhaps the most notable election-related news event for the food industry was the defeat of California’s Prop 37 initiative. This is not the end of the story, though, for GMO labeling initiatives. You should keep an eye on other attempts to mandate GMO labeling over the next 4 years. Expect labeling in general to become more important to consumers and expect FDA to increase their efforts in labeling enforcement related to misbranding and ingredients. In anticipation we’ve launched these 5 new websites to assist companies in obtaining a fast, accurate flat-rate label review.
Conclusion
The single most important thing that companies can do to prepare for the unknown is to have a partner on their side- a partner with experience, knowledge and tools to help minimize compliance risk during this unusual time. That partner is us. As always, simply contact us with your questions or issues and stay tuned!
