The FDA/USDA Cooperative Agreement: A Step Toward a Single Agency?
Updated: Nov 22, 2018
I have always been an advocate of a single food safety agency – but also very realistic in recognizing that it will probably never happen. The inefficiencies of our current dual regulatory process are evident wherever you look and anything that is focused on resolving that problem is a move in the right direction.
I don’t think my views are unique, and believe that it’s a very prevalent perspective – both within and outside the food industry – that the U.S. government’s approach to food regulation is too fragmented and should be streamlined.
While we are clearly not quite there, FDA and USDA did take things into their own hands in January, formalizing an interagency agreement for increased cooperation and coordination. According to a statement from FDA Commissioner Scott Gottlieb, he and U.S. Agriculture Secretary Sonny Perdue have worked together over the last several months and “identified several areas where we can strengthen our collaboration to make our processes more efficient, predictable, and potentially lower cost to industry; while also strengthening our efforts to ensure food safety.”
Perhaps this signifies a first step toward fulfillment of GAO’s January 2017 recommendation for the development of a national strategy, as we discussed in our newsletter, GAO Takes on Challenge of Defragging the U.S. Food Safety System … Again.
With the purpose to “document and formalize” the agencies’ ongoing collaboration, the new agreement includes USDA/FDA plans to establish interagency workgroups to improve coordination on issues of common concern including (but not limited to):
Dual-Jurisdiction Food Facilities. With USDA regulating certain meat, poultry and egg products and FDA regulating all other foods, the two share jurisdiction over food products in interstate commerce. Under that framework, a number of food processing facilities fall under the jurisdiction of both agencies. Because of that, the agreement aims to increase clarity, efficiency, and potentially reduce the number of establishments subject to the dual regulatory requirements of the USDA and the FDA. The example was given of a canned soup facility which produces both chicken noodle and tomato soup. Currently subject to regulation by both agencies, the agreement tasks both government organizations with identifying ways to streamline regulation and reduce inspection inefficiencies, while upholding safety standards for dual-jurisdiction facilities. This can reduce costs on industry and free government resources to better target efforts to areas of risk.
Produce Safety. FSMA’s Produce Safety Rule is the first regulatory framework specific to produce farms. Because USDA has the knowledge and expertise to support the FDA’s work related to farming. USDA and FDA have committed to enhancing their collaboration and cooperation on produce safety activities. FDA also is coordinating activities with state and/or territorial government agencies, which will conduct most farm inspections under the rule.
Federal Regulation of Biotechnology Products. The agreement also commits USDA and FDA to identify ways the agencies can better align and enhance their efforts to develop regulatory approaches to biotechnology, as each agency works to fulfill commitments outlined in the September 2016 National Strategy for Modernizing the Regulatory System for Biotechnology Products and the more recent Task Force on Agriculture and Rural Prosperity Report. These initiatives established a vision for increasing transparency, predictability and efficiency of the regulatory processes for biotechnology products.
It’s not the first time the agencies have inked such an agreement. In 1999, an MOU between FDA and USDA’s Food Safety and Inspection Service (FSIS) was signed to “facilitate an exchange of information between the agencies about establishments and operations that are subject to the jurisdiction of both.” It, too, was intended to increase the efficient use of resources and contribute to improved public health protection. And that agreement was based on the re-evaluation and updating of a 1983 MOU on the coordination of inspectional efforts between FDA and FSIS. As in the previous MOUs, the current agreement clarifies that the authorities of neither agency will be lessened, and adds that no financial obligation is made or funds transfer authorized.
The agreement is to extend for 10 years, with an annual review – and a few contingencies. That is, it includes a 60-day opt-out or change notice clause, and states that it is “contingent upon the availability of funds appropriated by the Congress.” A very practical clause, but also interesting given the fact that we know that FDA has been short of funds and resources for a long time already. But, if the agreement plays out as intended; the agencies’ regulatory responsibilities truly are streamlined; and their resources are used more efficiently to protect public health, it should help FDA extend and better allocate the limited resources it has. Clearly moving catfish regulation from FDA to USDA is not a good example to follow in terms of focusing expertise and saving money! But then one always has to keep in mind that politics will trump any logic.
Overall, I see the agreement as a good thing, even if it is just a step in the right direction. As I said in last year’s newsletter and noted above, I have been in favor of a single food safety agency for a long time. I see it as especially positive that USDA signed the agreement, as it was not so supportive of GAO’s national strategy recommendation. At least some of that is likely due to USDA’s seeming aversion to adopting a clear risk-based approach – which is the very foundation of FDA’s policies, as emphasized in FSMA.
So, I recognize that combining the agencies into a single entity is not likely to happen any time soon. But the more steps that are taken toward that end – be it a GAO push for a national strategy or an interagency agreement for cooperation – the more the philosophies and strategies of the two should begin to align. And the closer we may come to jurisdictional unity.
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