Food Safety Priorities—Your Thoughts on FDA's Proposed Reorganization

In Food Safety Insights, our goal is to bring you the best information on what is happening in the market and throughout the food safety business. We often do that by first selecting a topic to explore and then asking you and other experts for your thoughts and opinions.

Sometimes, however, we take another approach. Instead of first selecting a topic to explore, we ask you more open-ended questions about what thoughts are foremost on your mind. This was our approach this time. We asked open-ended questions about key topics in food safety to hear your opinions on the topics that you see as being most important. These topics included your priorities for your food safety program in the next 1–2 years, which regulations or issues you think will affect you the most in the near future, and which consumer issues will drive the most change. We also asked more specific questions, such as if your business has recovered from COVID-19, what related supply issues are you experiencing, and if you are able to find and hire the qualified people needed to run your food safety program.

We heard from nearly 200 food safety professionals on these and other topics. Over the next few issues, we will present what we learned here in Food Safety Insights. In this column, however, we will focus on your feedback on one very big issue—your opinions on FDA and the impending reorganization of the Human Foods program.

Your Thoughts on the Proposed FDA Reorganization

It is safe to say that we have all heard about the potential changes at FDA and the future of the Human Foods program at the agency. You are probably familiar with the Reagan-Udall study and its recommendations for options for the reorganization, including separating the food regulatory functions into a separate organization within FDA or even establishing a completely separate and new federal agency. Those of you who responded to our survey made it clear that you kept up on these details in Food Safety Magazine over the past few months, and it was also clear that you have strong opinions on the topic of this separation and equally strong recommendations on what FDA should try to achieve with this transformation.

To clarify your position, we first asked if you were indeed in favor of a separate food infrastructure within FDA or as a separate new agency. In our survey, 60 percent of those with an opinion were in favor of a food regulatory agency separate from the other functions of FDA, with 40 percent opposed (Figure 1). Interestingly, even though FDA is a U.S. regulatory agency, the opinions on this issue varied only slightly for those within or outside of the U.S. The percentage of those within the U.S. who favor a separate agency was only a few percentage points higher than those from outside the U.S. The ratio of those for or opposed to separation was literally universal.

To understand why this was so, we also asked what would be the most impactful change from a separate food agency. As expected by the "yes" votes, many people had positive views toward a future with a more focused, separate, food-only agency. Many people focused their comments on the ability of the agency to focus and specialize on food and to have fewer internal struggles and competition for resources with programs devoted to drugs and medical devices.

A few people put this succinctly by saying, "FDA should focus on drugs only," and that a separate food agency will have a " …more holistic view of food safety and with no distractions from drugs or medical devices." Some said that the new agency would have more resources to help food processors more by increasing the frequency of inspections and offering more assistance with training.

Another commenter summarized this sentiment by stealing a line from FDA itself: "… a separate food agency would have more power and focus to educate before they regulate." Others supported the idea of a separate food agency by suggesting that not only should the food responsibilities of FDA be separated, but that there should be one overall agency focused only on food. Several commented, "…the new agency for all food should be the existing FDA programs merged with USDA FSIS… Just have the USDA adopt the food portion of FDA. Why create another department… when you can… expand what you already have. Otherwise, a separated agency removed from FDA would still be a whole other program to develop and maintain, and you would still have multiple food agencies in place."

Keep in mind, however, that we still had 40 percent opposed to the idea, so not everyone was in favor of a new agency. Many people recognized that separating the food functions of FDA would create an agency with more focus on food, which would not necessarily be a good thing. Many suggested that this focus would lead to "…more investigators and more routine audits," and "…more regulation doesn't necessarily equate to improved compliance or better food safety." Others suggested that a new division or separate food agency might create more complexity rather than streamline the process, with one respondent saying a separate agency "…would create more bureaucracy, government oversight, confusion, cost, and conflict with less efficiency, less consistency, and less effectiveness." Another added their vote against creating a new agency, saying, "…we should fix FDA and not increase the already diluted expanse of food regulations."

Changes You Would Like to See at FDA

Since FDA has announced its intention to reorganize (although we do not yet know what that will look like), we also asked, as it embarks on this process, what are the most important specific changes the agency should make in that process.

The most common answers (Figure 2), accounting for close to three-quarters of the total comments, fell into three major categories:

1. Provide for more oversight and inspection
2. Streamline and prioritize the agency's operations and focus on food
3. Develop better and faster communications with the regulated community.

The largest number of comments concerned inspections and making them more frequent, more effective, and more focused on risk reduction and prevention. Many called for more frequent inspections, with one commenter saying we need "…better and more timely inspections," and another adding, "…hopefully more visits, with more direction and better assistance with our training" would be a welcome change because "…having an inspection once every 2–3 years isn't very effective."

People also made it clear that they would like the inspectors to be more active and more involved in processes at the plants they inspect. They asked for inspectors to help them with training and process improvements. Some asked for inspectors to weigh in on their food safety culture (including a way to measure and grade it), and to have the time and "bandwidth" available to offer additional guidance while onsite, including with pre-op preparations. One commenter said, "FDA should follow the example of FSIS… with frequent plant visits conducted by subject matter specialists similar to FSIS." [This comment echoes the fourth most common (14 percent) comment suggesting that FDA should be more focused on having inspectors specialized in the specific processing areas that they inspect, similar to FSIS inspections.]

Others wanted the agency to focus on becoming more efficient and "streamlining" its processes, and also to establish a greater focus on the areas that pose the most food safety risk. One respondent suggested, "Reduce the number of agencies and offices, and be able to make decisions faster. The current structure is unwieldy." Others asked for FDA to refocus on the areas of the greatest risk, where the most public health benefits can be gained. Commenters said the agency should "Ensure more consistent inspections and the ability to focus on high-risk products," and inspectors should be empowered to be more flexible and allow them to interpret "… rules applicable to situations, based on risks, not just broad over-reaching things that don't make sense to every type of facility or product." Again echoing FDA in its own words, another respondent added that inspectors should prioritize "…education before enforcement for low-risk operations."

Food processors also asked to see better and faster communication from the agency—both in terms of regulatory responses on specific issues and questions related to inspections and regulatory enforcement, and in terms of having a wider attention to communications and training on regulations and guidance. They want the agency to give them a better understanding of the regulations and requirements plus the informational and educational tools to be able to achieve effective compliance and continuous improvement in their own processing operations. One ingredient manufacturer said they would like to see the agency "…have clear and separate leadership in the food regulatory field," and with better communication and the ability to respond more quickly, the agency "…hopefully will lead to faster action and response times to major food safety incidents."

Seeking a More Efficient and Effective FDA

Clearly, opinions run strong on the future of FDA, and processors are looking for clear direction on where the agency will go in the future. The majority of the individuals in our survey are looking for a more efficient and effective FDA, one that is focused on food, and hopefully one that can be a partner in the effort for a higher level of food safety. Others are skeptical. Even though they want the agency to be more efficient and effective, they wonder if the new agency/department will be—or can be—properly focused, or if it will merely be an expansion of an already "unwieldy" bureaucracy.

In the next Food Safety Insights column, we will continue to explore what you have told us about your current and near-term priorities for your food safety programs, as well as the regulations and issues you are watching that will have the most impact on your programs in the future.

Bob Ferguson is President of Strategic Consulting Inc. and can be reached at bobferguson9806@gmail.com or on Twitter at @SCI_Ferguson.