When the U.S. Food and Drug Administration (FDA) rolled out its long-anticipated New Era of Smarter Food Safety blueprint in mid-July, there, tucked into the Four Core Elements of the plan, was the concept of domestic mutual reliance. The New Era of Smarter Food Safety represents a new approach to food safety, leveraging technology and other tools to create an integrated, safer, and more digital, traceable food system.
The plan states, “The themes of mutual reliance between federal and state partners and the importance of food safety culture are woven throughout.” The plan outlines FDA’s intent to build on existing efforts to partner with states that have comparable regulatory and public health systems, leveraging each other’s data and analytics to ensure optimal use of resources and maximize the food safety reach of both the states and FDA (see “The Math of Mutual Reliance,” p. 37).
So, you might ask, what is domestic mutual reliance, what are those existing efforts exactly, and how can we learn from them?
“Across the board, the integrated food safety system and mutual reliance has been a concept out there, a ‘nice to have’ but ‘pie in the sky’ type thing,” says Erik Mettler, assistant commissioner for Partnerships and Policy within FDA’s Office of Regulatory Affairs. “FDA is committed to enacting a comprehensive effort to make domestic mutual reliance a reality.
“In short, the concept of mutual reliance is an integrated workforce toward food safety,” Mettler continues. “We are in partnership with the states. We are sharing data. We are leveraging each other’s staff. We are sharing resources. It’s a free flow of information and activity back and forth—local level to the federal government. It’s a huge concept for people to grasp for a variety of different reasons.”
Mettler says the concept is playing out with several states. “We are doing tangible things to get to that end point. The end point may not be today or tomorrow, but it will be down the road,” he says. He also notes that the partnerships are working. States included in these initial formal efforts include California, Florida, Minnesota, New York, and Wisconsin (see “Win-Win Partnerships Take Different Forms,” p. 38).
A State-by-State Approach
Domestic mutual reliance is not a one-size-fits-all concept. Every state’s needs, resources, personnel, and culture are different. But being able to apply approaches across the country will be key to success.
“We can apply pieces to each state’s own unique programs,” Mettler says. “We work with each state—that way, it’s a give-and-take. We can swap successful approaches between programs and share the best practices. Then you have two viable programs and multiple components rather than starting from scratch over and over.”
Mettler makes it clear that mutual reliance is not something that just started happening recently.
“There is a lot of wear and tear on the concept of an integrated food safety system,” Mettler adds. “We started the concept three decades ago. We are making progress. This partnership improves industry compliance to reduce foodborne illness outbreaks and increase public health protection in our integrated food safety system, and these examples are what it looks like in different scenarios.
“I think there is a lot of reliance happening already without being called out,” Mettler says. “The retail program is the pinnacle of what mutual reliance could be. FDA sets the standards at a federal level, and the state and local level actually implement it. The Produce Cooperative agreement is another prime example.
“Our present focus is identifying all the pieces that we are currently doing and use them to develop a road map that moves us forward. We are heading in a direction, not just doing one-offs. We are leveraging lessons learned and incorporating them back into our processes.”
Necessity Is the Mother of Invention
Joe Corby was a New York State program manager long before he became the executive director of the Association of Food and Drug Officials (AFDO). Although Corby now serves as an AFDO senior adviser, he still gets excited speaking about the role mutual reliance plays in an integrated food safety system.
Corby says that the earliest mutual reliance agreements came in the realm of regulating pharmaceuticals, where FDA developed agreements with the European Union (EU). Today, FDA can officially rely upon drug manufacturing inspection reports from the regulating authorities of 28 EU countries. The concept is simple: Inspectors from EU countries perform inspections in their respective countries, FDA inspectors inspect the manufacturing facilities in the United States, and the EU and FDA rely upon each other. This avoids any duplication, lowers costs, and enables regulators to devote their efforts to higher-prioritized concerns. Corby says, “If mutual reliance can work for FDA with foreign countries, then it can work with FDA with state food safety programs.
“Mutual reliance establishes a confidence in another country or state that their programs are equivalent, and parties are satisfied that they each can make appropriate public health decisions,” Corby says.
The genesis of the FDA/New York Agriculture & Markets import program initiative more than two decades ago resulted from continuing repeat violations in two different regulatory worlds that intersected at retail markets where consumers are impacted.
“Inspectors in New York would go into the retail markets, especially ethnic food stores, and they would find a problem with an imported food product,” Corby recalls. “We would get this product off the market, coordinate a recall, supervise its destruction, and the product was gone. Shortly thereafter, we would find the same violative product imported into the country and marketed again. Part of the FDA mutual reliance agreement with New York was for providing information to FDA so they could issue import alerts to prohibit these products from entering the country. Alone, New York could not prevent those products from coming back into the country. Only FDA can do that. This problem could only be resolved through the mutual reliance agreement that was established.”
The latest iteration of mutual reliance in New York State focused partly on addressing high levels of lead and other heavy metals found in imported spices. Steve Stich was working as director at the New York State Department of Agriculture and Markets Food Safety and Inspection Division when the project kicked off in 2016.
“Our past experience had built knowledge of, and confidence in, each other’s programs, increasing reliance on each other and trust,” says Stich. “FDA and the states have different strengths and enforcement capabilities. The biggest hurdle for the mutual reliance project was having the analytical packages from our food laboratory being accepted by FDA. So, FDA created a checklist for analytical packages. What are they going to need to see in order to accept the sample and not have to go out and get their own sample?
“The FDA acceptance rate has gone up three times over the past couple of years. It doesn’t have to be 100 percent acceptance to be successful,” Stich notes. “FDA was able to better understand New York’s lab capacity and capability. I think New York Ag was able to better understand FDA’s processes. Just understanding each other’s programs and how to work together—not around but through some of the hurdles.”
Mettler says need has also driven inspection projects like Florida’s.
“First, FDA cannot touch the inventory we need to. Second, we are looking at the public health analytics at the end of the day,” Mettler says. “If we go in and do an inspection, or a state goes in and does an inspection, what is the public health outcome? It’s pretty much going to be the same. I have not seen that one inspection is better than the other. It’s just a different way to go about achieving that public health end goal.”
Corby and Mettler both say that it is not a matter of agreeing that both federal and state approaches are right—they are just different.
The Math of Mutual Reliance
When you talk with Michael Rogers, FDA’s assistant commissioner for the Office of Human and Animal Foods Operations, about the partnership his group designed that was successfully tested in Florida and now Wisconsin, there is no lack of clarity about what drove the initiation of this win-win, as Rogers calls it. Work planning painted a difficult picture for FDA.
“Between FDA and the states, we need to conduct about 18,600 inspections per year, recognizing that high-risk firms are inspected every 3 years and non-high-risk firms are inspected every 5 years. There are also other inspections we are required to conduct as well as unplanned work,” Rogers explains. “We also recognized that if we allowed the inspection frequency mandate to drive the inspections, there would be some years where we would be inspecting more non-high-risk firms than would make sense from a risk-based and priority-setting perspective. One of those years is FY22. We thought about ways to leverage the work that the states have done to have that work count toward the inspection-frequency mandate. We also recognized that states in full conformance with the Manufactured Food Regulatory Program Standards were ideal to establish this relationship with.”
FDA achieved this milestone with the Florida Department of Agriculture and Consumer Services (FDACS) by completing a proof-of-process initiative. These noncontracted inspections conducted by FDACS have been accepted into FDA’s data systems, and the resultant inspection adjusted the “cover-by date” out 5 years.
Rogers says the give-and-take is not without challenges.
“The initial group of firms in Florida was about 10. We are now up to more than 230. It’s saving the FDA significant resources,” Rogers reports. “First, we are leveraging the states and that is truly mutual reliance—not duplicating work and reducing the burden on industry. We pay the states $750 per inspection. If we were to do it on our own, the cost would be $21,000 per inspection. When you look at over hundreds of firms, the agency has saved over a quarter of a million dollars so far. This program will continue with Florida, Wisconsin, and other states and will save the agency tremendous resources over time and will further advance the agency’s mutual reliance efforts.
Some states like Florida have their own inspection frequency mandates, and they have started counting our inspections toward their mandate numbers, which is another step toward mutual reliance,” Rogers notes.
The metrics are significant when you expand the possibilities nationwide, and Rogers says FDA is ready to adopt the protocol.
It just makes sense from a regulatory standpoint to combine resources. It makes sense from an industry standpoint because it reduces the burden on industry by minimizing the number of inspections that regulators need to ensure that firms are in compliance. This is a win-win arrangement that will be our standard approach and protocol moving forward,” Rogers adds.
Recipe for Mutual Reliance Is Not Cookie-Cutter
Mettler and Corby also agree there is more work to do and a need for a culture shift.
“The concept and the actualization of mutual reliance has been there for quite some time. You are going to have these pockets where the states and FDA division directors get along very well and they have already adopted this mindset,” says Mettler. “What has been missing is that continued state of a clear goal and a systematic process to get there along with the culture shift. It will be 50 different versions of mutual reliance at the end of day because each FDA/state partnership will apply these concepts differently. We will never end up with every single state being the same, nor should we.”
Mettler says having mutual reliance as a core element of the FDA’s New Era of Smarter Food Safety blueprint will push things along.
“Mutual reliance is a key part of an integrated food safety system. The blueprint is helping achieve that road map for that system. Everything in the blueprint is giving us one more tool, one more aspect of moving the ball down the road. Mutual reliance is in there and it ensures that we are carving it out and making sure it moves forward,” Mettler says.
“With the end goal being a safer food supply and public health, we are partnering with those who have the same mission. For the FDA, there is a huge resource gain—getting after that inventory that we are not going to get after ourselves. Looking several years down the road, the pressure of the amount of food coming in internationally is going to demand FDA’s attention, and if that is where we are required to put our attention, the states are a must for taking care of domestic food safety,” Mettler says.
Win-Win Partnerships Take Different Forms
Perhaps the most well-known mutual reliance proof of process involves using non-high-risk, noncontract, nonviolative inspections from a state that has achieved full conformance with the Manufactured Food Regulatory Program Standards (MFRPS) to fulfill the Food Safety Modernization Act (FSMA) inspection frequency requirement mandated under Section 201 of FSMA.
In an effort to further strengthen and operationalize the Integrated Food Safety System, FDA has initiated a new pilot for those states in full conformance with the MFRPS.
In June 2019, FDA reached this milestone with FDACS by completing a proof-of-process initiative. These noncontracted inspections conducted by FDACS have been accepted into FDA’s data systems, and the resultant inspection adjusted the “cover-by date” out 5 years.
The Wisconsin Department of Agriculture, Trade, and Consumer Protection (WDATCP) was the second state agency to participate in this initiative. The WDATCP and FDA engaged in a 12-month pilot covering manufactured food, specialized inspections, and dairy, excluding dietary supplements and infant formula. The main goals were to minimize duplication of inspectional work and increase integration and collaboration among the agencies in compliance and enforcement, emergency response, laboratory, inspectional planning and fieldwork, and improved information sharing and resource allocation.
FDA’s Office of Regulatory Affairs is working to expand this initiative to other MFRPS-conforming states and leveraging work done by other states. Minnesota’s 2020 start date was delayed by the pandemic. In addition to serving as an incentive for states to achieve full conformance in MFRPS, it is envisioned that this process could also be a model for animal food and states conforming with the Animal Feed Regulatory Program Standards.
The California Department of Public Health engaged in an 18-month, three-phase pilot with FDA. The pilot covered domestic food (to include specialized inspections for juice, low-acid canned and acidified foods, and seafood) exclusive of eggs, dairy, and animal food, which are regulated by the California Department of Agriculture. The focus was collaborative inspectional and compliance activities and improved data sharing.
The New York State Department of Agriculture & Markets and FDA are engaged in a 24-month pilot. The primary goal is to increase integration in laboratory review and analysis of imported products sold at retail and provide FDA with the basis to initiate appropriate compliance actions against importers and violative imported products based on state analytical data.
Corby says it really boils down to whether program managers at the state level really want an integrated food safety system. “Mutual reliance provides us the best way to get to an integrated system,” Corby advocates. “Most states largely conform or completely conform with manufactured food regulatory program standards, so that should not be a challenge to mutual reliance. Some other elements could be a challenge, but if we just start off with the elements we all agree on, we can and should head in the right direction.”
Stich says there is much to be gained by states that are willing to participate. “It all starts with relationships, communication, and understanding each other. If you have that relationship with your FDA division, then you are off to a good start,” he says. “There has to be a mutual desire to approach the project in the first place.”
Corby says that proclaiming the importance of mutual reliance is important to moving to the next level. He points to the inclusion of mutual reliance as a core element of the FDA’s New Era of Smarter Food Safety blueprint as a start but not the end-all to moving things along in support of an integrated food safety system.
Corby says metrics are the key to moving states to action.
“Does the rest of the country know how many times New York laboratory work resulted in an import alert from FDA?” he says. “Do they know how successful the inspection-sharing program is in Wisconsin and that it is eliminating duplication and reducing the need for resources? Do they know how successful the California work-planning program has been? Work planning is where it all starts. You have to illustrate success with metrics, and when people learn about success, then they want to do it too.”
Steven Mandernach, executive director of AFDO, shares the enthusiasm for mutual reliance’s place in the FDA’s blueprint.
“It’s time to move to action. These FDA partnership projects, no matter what they have been called, have proven mutual reliance does work and is a valuable foundation for an integrated food safety system,” says Mandernach. “Now it’s time to bring program staffs, state and federal, together to [create] mutual reliance in the best interest for food safety and in turn everyone.”
Brooke Benschoter, APR, M.Sc., supports AFDO and its mission as the director of communications. She received her M.Sc. in leadership development, organizational development, and adult learning from Drake University.