Is the FDA sliding into your DM’s?
Editor’s note: Each Spring, attorneys Bill Marler and Denis Stearns teach a Food Safety Litigation course in the LL.M. Program in Agricultural and Food Law at the University of Arkansas School of Law. This specialized program for attorneys brings together those who are interested in our food system, from farm to table. As a final assignment, students are asked to write an op-ed or essay on food safety, with the best to be selected for publication in Food Safety News. The following is one of the essays for 2021.
By Kyla Kaplan
An overview of how the “next step” in the FDA Technology Modernization Action Plan (TMAP), the New Data Modernization Plan (DMAP), will impact the world of food safety through a three-pronged approach.
On March 3, 2021, the Food and Drug Administration (FDA) published a blog post to present their next step in jumping on the tech bandwagon. The agency first released its plan to get up-to-date in a digital world back in 2019 under the name the Technology Modernization Action Plan (TMAP). TMAP was viewed as a framework to build off of and now the New Data Modernization Plan (DMAP) is the next step in making the goals of TMAP a reality. The overarching goal is to promote “the stewardship, security, quality control, analysis, and real-time use of data to accelerate the path to better therapeutic and diagnostic options for people and animals, better secure the food supply chain, and provide state-of-the-art tools to enhance and promote public health.”
There is no debate the FDA has needed to modernize its programs to meet consumer needs, such as food safety, in a digital world. Further, the FDA’s volume and variety of work is continuously expanding, almost as fast as the digital world is diversifying, and the FDA needs to be able to work within this structure to make “science-based regulatory decisions.” Nonetheless, it is not always clear how a shiny new program like DMAP, will actually go about impacting consumers and their need for access to safe, healthy, and suitable food.
Specifically, how can a digital platform “better secure the food supply chain?”
Below we will analyze and dissect the FDA’s three-prong plan under the DMAP, focusing specifically on how this plan will improve the food supply chain. While DMAP touches on all areas that FDA regulates, this essay will focus on how the three prongs: (1) Strong Driver Projects, (2) Data Practices, and (3) Talent Development, impact food specifically.
Strong Driver Projects
A “driver project,” under DMAP is an “initiative with measurable value that helps multiple stakeholders envision what is possible, allows technical and data experts to identify needed solutions, and develops foundational capabilities.” Basically, what that means is that when FDA is monitoring either a food or drug commodity, a digital program will be used to monitor and collect the information about what works and what does not. Then, once information has been collected, essentially the data, through data experts, will be utilized to turn the gathered information into productive and feasible solutions to complex problems.
One example where FDA plans to put the idea of a “driver project” into action is the identification and incorporation of lessons learned from artificial intelligence (AI) in a “seafood pilot for import inspections” and the ability to then take the AI gathered from seafood commodities to “scale the capabilities for other food and medical imports.” Specifically, due to the fact that the U.S. imports a large majority of its seafood, the FDA used a two-phase approach focused on machine learning and data collection to identify potentially harmful seafood shipments. The ultimate goal is to be able to learn from the data collected on seafood imports and then apply it to learned principles to other commodities.
Building off of the concept of driver projects, part of technology modernization is making sure that steps are taken to be as efficient as possible while still maintaining accurate results. Many of the tasks that the FDA undertakes are repeatable; the ability to identify data for a problem and solve it without having to start at ground zero would divert 50 percent to 75 percent of the time the FDA spends currently performing repeatable tasks to new problems.
The way FDA plans to reach its data practice goals and minimize repetitive work is through identification, data curation, governance, and systems automation. Let us break these concepts down:
Identification — Effective solutions require the “ability to identify the right data with the appropriate quality and completeness.” For example, we have all seen information about food products out there that is not accurate, and it can be challenging to sift through and make sure you are cultivating accurate information. The FDA is making a point to recognize the importance of sound data collection before making changes.
Data Curation — Generally, a fancy way of saying data collection; However, data curation involves more than just simply collecting data. Through data curation, the FDA will hopefully be able to characterize, classify, and develop “fit for purpose” services to match needs. Thinking about food safety, the focus it seems should be on tech-enabled traceability. Currently, through the Food Safety Modernization Act (FSMA) and FDA’s Smarter Food Safety plan, the FDA has recognized that the supply chain needs faster traceback to identify and quickly remove contaminated products to mitigate any risk. However, to do this there must be a system in place, compliance from producers, and a way to generate information quickly and accurately for consumers.
Governance — A strong and central governance system will be essential to not only transmit information in a succinct way but also to minimize consequences of the food supply such as food waste. For example, a governance system that can make cohesive date labels will minimize the risk of food spoilage and as a result, ensure that food on the shelf is safe to be sold. Governance goals are likely to be challenging to reach though because in the U.S. we do not have a central food agency. While FDA can control the products it is tasked to oversee, the FDA will not be able to control the choices other agencies make such as the U.S. Department of Agriculture (USDA), the Centers for Disease Control and Prevention (CDC), or the Federal Trade Commission (FTC). This will likely be one of the largest barriers to seeing a large impact on food safety using technology.
Automation — For several years now, advocates have been pushing to incorporated automated systems such as robotics and software collection in food safety practices both in stores and in production facilities. Other industries have not been afraid to utilize automation, but in many ways, the food system has shied away. That being said, there is certainly a role for automation systems to play when it comes to tasks such as executing food safety plans before, and when, problems arise. Examples include an automation system that could quickly change product labels when they are inaccurate or wipe the shelves of a contaminated product without causing large-scale disruptions.
Last is the “who,” meaning who is going to make all of this happen and what will these individuals need to be capable of. Nothing about the DMAP will be possible without FDA hiring experts to execute ideas and create a flexible operating system; meaning that the system created can be used in a number of different ways through turn-over of staff, product, and consumer demands.
As we all know, the food system is quickly changing and will continue to change with trends, new ways of shopping for food, and other social and environmental changes. This means that a system put in place under DMAP needs to be extremely adaptable to these changes.
Within DMAP, FDA writes about the skills that will be needed for “successful data science practice.” These include, “in addition to data science experts, there is need for domain experts, data modelers, computer and software engineers, statisticians, software engineers, data modelers, storytellers, product managers, and agile practitioners.”
It should not be overlooked that these science experts should have a personal and/or professional appreciation for the fluidity and the reality of the food system, along with their science-based skillset. The food system, especially the sub-set that encapsulates food safety, is unique when compared to, let’s say, other product sales like clothing or real estate. Some of the ways the food system differs are from a foundational perspective that food is essential to human life. Further food access relates deeply to people in the cultural context, and it is a highly scrutinized industry as a whole when it comes to health and the environment. Therefore, all the science in the world will not be beneficial in the long term if those who are creating the data systems do not appreciate the reality and practices of the U.S. food system.
The Future of the Execution DMAP
We are in a world concerned with smarter food and smarter food safety. Building from this foundation under TMAP, the FDA, under DMAP, has a strong platform. It seems that among other things, the platform can ultimately provide an avenue for a more efficient and more productive food supply chain. However, especially in a pandemic environment and then a post-pandemic environment that will linger for years to come, it will be interesting to see how quickly these plans come to fruition. It is fair to be skeptical about the speed at which the agency will take action on this, but at the same time important to be hopeful that in a world where efficiency is everything, efficiency in data management can also be used to protect consumers’ food supply.
The FDA should continue to be transparent about data modernization in the food safety arena and how DMAP is being rolled out. The FDA should do this by creating a flexible, but workable data identification and collection system that optimizes consumer safety and allows FDA to focus on new problems rather than repeatable issues that should have a step-by-step solution. The FDA should also be collaborating with other agencies to create a cohesive system for management, not only with food safety but with other FDA commodities. Lastly, while FDA has already said in DMAP that it will be hiring with a focus on “talent development,” the hires should also have an appreciation for what FDA is generally tasked with and the food system as a whole. If the people creating the system do not appreciate the history and common problems the food system faces, DMAP will not result in the permanent infrastructure it is seeking to construct.
About the author: Kyla Kaplan earned her bachelor’s of science degree from the University of Wisconsin-Madison in environmental studies and journalism. She earned her law degree from the University of Maryland Carey School of Law in Baltimore, MD. She is a Master of Law candidate in Agricultural and Food Law at the University of Arkansas in Fayetteville, AR, where she is also an Advisor for the Journal of Food Law & Policy. She previously externed with Tyson Foods Legal Counsel and is now doing a practicum with the Food Safety and Compliance team at Walmart in Bentonville, AR. Kaplan has also interned at the Center for Science in the Public Interest (CSPI) in Washington D.C. as well as the Harvard Law School Food Law and Policy Clinic in Boston, MA. She plans to work as a regulatory attorney, supporting food, drug, and agriculture clients.