Last week, President Obama proposed a FY 2017 budget which requested an increase of $25.3 million of new budget authority for FSMA. With five of the seven final rules having been issued in 2015, and the final rules for two more – sanitary transportation and intentional adulteration – due March 31 and May 31, 2016, respectively, FY 2017 spending will no longer be on writing the rules, but on their implementation. The increase, for the period of Oct. 1, 2016—Sept. 30, 2017, is in addition to the $104.5 million new budget authority FDA received for FSMA for FY 2016. FDA sees the additional FY 2017 funding as essential to meet congressional and public expectations of FSMA, and “fully realize the public health and public confidence benefits promised by FSMA.” FDA intends to focus the requested monies on the implementation of two of the seven rules: Produce Safety and FSVP. Produce Safety. $11.3 million is planned for the implementation of the National Integrated Food Safety System to support state capacity to implement the rule through education and technical assistance to farmers, as well as ongoing compliance support and oversight. This collaboration with state, local and tribal governments is a central element of FDA’s strategy to fully and efficiently implement FSMA. But the funding is needed because the states cannot perform their roles without federal resources. In addition to supporting the development of state produce safety oversight programs, the monies will be used to fund on-farm readiness reviews before the produce safety rule compliance dates hit. With its 2016 funds, FDA is continuing work toward enabling funding for top agricultural states to develop a produce safety program that clearly defines the roles and responsibilities of each state agency. It has also been laying the groundwork for on-farm readiness reviews, funding state development of animal feed regulatory standards, and funding cooperative agreements to support training. Thus, as expected, we see a lot of the produce regulatory oversight being passed down to the state level by FDA. This makes sense in that the states will have a better sense of risks in their own state. What will be key in all of this is to use this funding to not only help farmers become compliant but also to ensure that the state regulators are up to speed on how to enforce FSMA. $14 million is intended to develop a New Import Safety System to implement the FSVP rule. This rule makes importers responsible for ensuring that the foods they import are produced in a manner that is consistent with U.S. food safety standards. FDA will use the funding to: Ensure FDA’s FSVP readiness, hiring staff to perform FSVP inspections, and provide training, technical assistance and outreach. Educate industry to encourage voluntary FSVP compliance. Implement the FSVP rule through oversight of importers required to comply with the preventive controls rules. Expand its overseas presence, increasing and better targeting FDA inspections of foreign food facilities. Work with and assist foreign governments in food safety, collaborating with foreign regulatory partners and industry. In addition to these two FSMA initiatives, FDA is already working on: Modernizing its inspection system and training FDA and state staff accordingly. Developing FSMA guidance, education and technical assistance for industry. Building state capacity to partner with FDA on FSMA implementation. Establishing an import safety system that addresses problems before food for import reaches the U.S. We are often asked the question as to whether FDA will have the resources to fully implement FSMA. As you can see from these new budget requests they are clearly getting there in terms of resources. But what does this mean? Will we see a whole lot more FDA inspections? – I think not. Currently FDA is not on the farms unless there is a specific cause – this funding will not change that; but it will put state inspectors on farms in more of an “FDA” regulatory capacity. It will mean the FDA will be showing up to inspect importers to ensure they are compliant with FSVP – again something that is not happening today. So, for the average food plant I don’t anticipate a big increase in the number of FDA inspections. What will change during routine inspection is FDA requesting to see your Food Safety Plan, and that is what you need to prepare for. Specifically, think about how you will respond when an FDA inspector says “show me your Food Safety Plan.” Be ready to give them the impression that you totally understand HARPC and that you have all your preventive controls in place with ongoing verification. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
